Herbal drugs

Table created by research student Cristina Donadiós.
Herbal drugDescriptionContentTraditional use (EMA)Well-established use (EMA)WHO Well-establishedWHO Traditional useESCOPBibliography articles NCBI
Acanthopanax Bark (Acanthopanacis gracilistyli cortex) 01/2012:2432Dried root bark of Eleutherococcus gracilistylusThe efficacy of Acanthopanax in pacients with acute ischaemic stroke, a mortal disease. (Li, 2009) (1)
Agar (Agar) 01/2009:0310Polysaccharides from various species of Rhodophyceae mainly belonging to the genus Gelidium.1. Prosthetic joint infections and its optimization (Heimann Larsen, 2012) (2) 2. Assays for rapid screening of patients at risk of drug-resistant tuberculosis (Minion, 2010) (3)
Agnus cactus Fruit (agni casti fructus) 01/2015:2147Whole, ripe, dried fruit of Vitex agnus-castus L.Content : minimum 0.08 per cent of casticin (C19H18O8 ;
Mr 374.3) (dried drug).
Traditional herbal medicinal product for the relief
of minor symptoms in the days before
menstruation (premenstrual syndrome).
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Herbal medicinal product for the treatment of
premenstrual syndrome.
Orally for the treatment of endometrial hyperplasia and secondary amenorrhoea; endocrine-dependent dermatoses (dermatitis symmetrica
dysmenorrhoica (Matzenauer-Polland syndrome)) acne vulgaris, eczema,
acne rosacea), hypermenorrhoea, infertility due to hyperprolactinaemia
and luteal phase defect. Used to treat fibroid cysts and infertility,
to stop miscarriages due to progesterone insufficiency, to help expel
the placenta after birth and also as a digestive aid, sedative, anti-infective
and for the treatment of hot flushes
Used as an anaphrodisiac, calefacient, contraceptive, emmenagogue, sedative
and as a tonic
1. Evaluation of the efficacy of Agnus cactus fruit in women with dysmenorrhoea (Aksoy, 2014) (4) 2. The use of agnus cactus fruit for Menopausal transition and it effects (Chopin, 2003) (5) 3. Lower cost of a solution for Mastalgia and Hyperprolactinemia with same results as Bromocriptine: Fructus agni casti (Kilicdag, 2004)(6) 4. Vitex emprovement in PMS (premenstrual tension syndrome) symptoms, added in Femicur®(Loch, 2000)(7)
Agnus cactus fruit dry extract (Agni casti fructus extractum siccum) 01/2015:2309Dry extract produced from Agnus castus fruit (2147).minimum 0.10 per cent of casticin (C19H18O8 ; Mr 374.3) (dried extract).
Agrimony (Agrimoniae herba) 01/2011:1587Dried flowering tops of Agrimonia eupatoria L.minimum 2.0 per cent of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1) (dried drug). Indication 1) Traditional herbal medicinal product for the symptomatic treatment of mild diarrhoea. Indication 2) Traditional herbal medicinal product for use as a gargle for the symptomatic relief of minor inflammations of the mouth and throat. Indication 3) Traditional herbal medicinal product for relief of minor skin inflammation and small, superficial wounds. The product is a traditional herbal medicinal product for use in the specified indications exclusively based upon long-standing use.INTERNAL USE: Agrimony has widely documented uses as a remedy to treat mild diarrhoea [4, 15, 16]. EXTERNAL USE: Locally as a gargle for inflammation of the oral and pharyngeal mucosa [4, 15, 16], and as a compress or rinse to support the healing of wounds [4, 6]. Efficacy in these indications is plausible on the basis of human experience and long-standing use.1. Findings if plant extracts with natural substances can work as antiosidants in broiler chicken organs. (Fejerčáková, 2014) (8) 2. DA-IBS formulation doesn't imporve in patinets with bowel habit with diarrhea, but it does in numerous IBS symptoms. (Hawrelak, 2010) (9) 3. Agrimony extract as supplement with clove in chickens of 42 days for their growth (Petrovic, 2012) (10)
Akebia Stem (Akebiae caulis) 01/2017:2472Dried stem of Akebia quinata (Houtt.) Decne. Or Akebia trifoliata (Thunb.) Koidz, or a mixture of the 2 species.minimum 0.15 per cent of oleanolic acid (C30H48O3 ; Mr 456.7) (dried drug).· A full study of Akebia stem and its application on medical treatments. (Gao, 2006) (11)
Alchemilla (Alchemillae herba) 01/2008:1387Whole or cut, dried, flowering, aerial parts of Alchemilla vulgaris L. Sensu latiore.minimum 6.0 per cent of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1) (dried drug). As an adjuvant in non-specific diarrhoea, gastrointestinal complains and dysmenorrhoea [Schimmer 1992; Scholz 1994; Jänicke 2003; Bradley 2006; Gerlach 2007; Schilcher 2007; Moeck 2007; Blaschek 2009]. Efficacy in these indications is plausible on the basis of human experience and long-standing use.·Study of Alchemilla in deep wound healings and its efficacy (Shrivastava, 2011) (12)
Aloes, Barbados (Aloe barbadensis) 01/2015: 0257Concentrated and dried juice of the leaves of Aloe barbadensis Mill.minimum 28.0 per cent of hydroxyanthracene derivatives, expressed as barbaloin (C21H22O9 ; Mr 418.4) (dried drug).NoneHerbal medicinal product for short-term use in cases of occasional constipation.Short-term treatment of occasional constipationTreatment of seborrhoeic dermatitis, peptic ulcers, tuberculosis, and fungal infections, and for reduction of blood sugar (glucose) levelsFor short term use in cases of occasional constipation [Schilcher 1979 ; Sigle 2007; Hiller 2009]
Aloes, cape (Aloe capensis) 01/2008:0258Concentrated and dried juice of the leaves of various of Aloe, mainly Aloe ferox Miller and its hybrids.minimum 18.0 per cent of hydroxyanthracene derivatives, expressed as barbaloin (C21H22O9 ; Mr 418.4) (dried drug).Short-term treatment of occasional constipationTreatment of seborrhoeic dermatitis, peptic ulcers, tuberculosis, and fungal infections, and for reduction of blood sugar (glucose) levelsFor short term use in cases of occasional constipation [Schilcher 1979 ; Sigle 2007; Hiller 2009]
Aloes dry extract, standardised (Aloes extractum siccum normatum) 01/2015:0259Standardised dry extract prepared from Barbados aloes (0257) or Cape aloes (0258), or a mixture of both.19.0 per cent to 21.0 per cent of hydroxyanthracene derivatives, expressed as barbaloin (C21H22O9 ; Mr 418.4), adjusted if necessary (dried extract).
Amomum Fruit (Amomi Fructus) 04/2014:2554Dried, whole or fragmented, peeled or unpeeled ripe fruit of
Amomum villosum Lour. or Amomum longiligulare T.L.Wu.
essential oil: minimum 30 mL/kg for A. villosum (anhydrous drug) and minimum 10 mL/kg for A. longiligulare (anhydrous drug); bornyl acetate (C12H20O2 ; Mr 196.3) : minimum 30.0 per cent of the essential oil.
Anemarrhena Asphodeloides Rhizome (Anemarrhenae asphodeloides rhizoma) 01/2016:2661Dried, whole or fragmented, peeled or unpeeled, rhizome of Anemarrhena asphodeloidesminimum 0.5 per cent of mangiferin (C19H18O11 ; Mr 422.3) (dried drug). 1. Study of the imporvement of Anemarrhena asphodeloides rhizome inpatients suffering from schizophrenia (Shi-Fu, 2011)(13) 2. The use of Anamarrhena Ashphodeloides in many difficult diseases for instance lung infection, sterility, and climacteric syndrome (Wang, 2014)(14)
Angelica Archangelica root (Angelicae archangelicae radix) 01/2013:1857Whole or cut, carefully dried rhizome and root of Angelica archangelica L. (syn. A. officinalis Hoffm.).minimum 2.0 mL/kg of essential oil (dried drug).· Angelica Archangelica helps to decrease the behavioral and psychological symptoms of dementia in frontotemporal lobar degeneration and dementia with Lewy bodies and treat them (Kimura, 2011) (15)
Angelica Dahurica Root (Angelicae dahuricae radix) 07/2015:2556Dried, whole or fragmented root, with rootlets removed, of Angelica dahurica (Hoffm.)minimum 0.08 per cent of imperatorin (C16H14O4 ; Mr 270.3) (dried drug).
Angelica Pubescens Root (Angelicae pubescentis radix) 01/2012:2557Dried root, without rootlets, of Angelica pubescens Maxim. f. Biserrata R.H.Shan et C.Q.Yuanminimum 0.50 per cent of osthole (C15H16O3 ; Mr 244.3) (dried drug)· Study of osthole,and its exhibition antioxidant,anticancer, anti-flammatory and much more (Zhang, 2015) (16)
Angelica Sinesis root (Angelicae sinensis radix) 07/2012:2558Smoke-dried, whole or fragmented root, with rootlets removed, of Angelica sinensisminimum 0.050 per cent of trans-ferulic acid (C10H10O4; Mr 194.2)1. Full study of Angelica sinesis and its application in science fields (Wei, 2016)(20) 2. Angelica sinesis injection in patients that suffered acute celebral infarction (ACI) (Liu, 2004)(19) 3. The effectiveness on preventing the developement of palmar-plantar erythrodysesthesia during chemotheraphy (Lademann, 2014)(18) 4. A better treatment program for active SLE, using PMC combined with LFJC (Song, 2014)(17) 5. The study of Chinese herbal treatments showed that the administration of RG-CMH in patients with chemotheraphy/radiotherphy treatment would represent a trategy for imporving patient immunity (Zhang, 2012)(22)
Anise Oil (Anisi aetheroleum) 01/2008:0804Essential oil obtained by steam distillation from the dry ripe
fruits of Pimpinella anisum L.
Indication 1) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastrointestinal complaints including bloating and flatulence. Indication 2) Traditional herbal medicinal product used as an
expectorant in cough associated with cold.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
None.Treatment of dyspepsia and mild infl ammation of the respiratory tract. As an aphrodisiac, carminative, emmenagogue, galactagogue and insecticide.
Treatment of chronic bronchitis
Aniseed (Anisi Fructus) 01/2012:0262Whole, dry cremocarp of Pimpinella anisum L.minimum 20 mL/kg of essential oil (anhydrous drug).Indication 1)
Traditional herbal medicinal product for
symptomatic treatment of mild, spasmodic gastrointestinal
complaints including bloating and
flatulence. Indication 2)
Traditional herbal medicinal product used as an
expectorant in cough associated with cold
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
No information available.Treatment of dyspepsia and mild infl ammation of the respiratory tract. As an aphrodisiac, carminative, emmenagogue, galactagogue and insecticide.
Treatment of chronic bronchitis. As an aphrodisiac, carminative, emmenagogue, galactagogue and tonic,
and for treatment of asthma, bronchitis, diarrhoea, fever, spasmodic
cough, fl atulent colic and urinary tract infections
Dyspeptic complaints and mild spamodic gastro-intestinal complaints, such as bloating, flatulence [Blaschek 2007; Czygan 2002; Weiss 1997; Pimpinella 1983; Sweetman 2011; Czygan 1992; Hänsel 1999] In mild inflammation of the upper respiratory tract, as expectorant [Blaschek 2007; Czygan 2002; Weiss 1997; Pimpinella 1983; Sweetman 2011; Czygan 1992; Hänsel 1999] In these indications the effects ara plausible on the basis of human experience and longstanding use. 1. Study of many herbal plants, including aniseed, have proved that can alleviate cough in consequence of any disease with formation of mucus (Büechi, 2005)(23) 2. Comparing tretaments of cough and its alleviation in Horses with airway difficulties (Pearson, 2007) (24)
Artic root (Rhodiolae roseae rhizoma et radix)Traditional herbal medicinal product for temporary
relief of symptoms of stress, such as fatigue and
sensation of weakness.
The product is a traditional herbal medicinal product for use in the specified indications
exclusively based upon long-standing use.
Arnica Flower (Arnicae flos) 01/2012:1391Whole or partially broken, dried flower-heads of Arnica
montana L.
minimum 0.40 per cent m/m of total sesquiterpene
lactones, expressed as dihydrohelenalin tiglate (dried drug).
Traditional herbal medicinal product for the relief
of bruises, sprains and localised muscular pain.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
NoneAs a topical counterirritant for treatment of pain and infl ammation resulting
from minor injuries and accidents, including bruises, ecchymoses, haematomas and petechiae. Treatment of infl ammation of the oral
mucous membranes, insect bites and superficial phlebitis. Treatment of indigestion, cardiovascular disease, and rheumatism. As an
emmenagogue
1. Discussion between traditional european medicine (Russo, 2013)(25)
Arnica tincture (Arnicae tinctura) 01/2008:1809Tincture produced from Arnica flower (1391).minimum 0.04 per cent of sesquiterpene lactones expressed as dihydrohelenalin tiglate (C20H26O5 ; Mr 346.42).
Artichoke Leaf (Cynarae folium) 07/2015:1866Whole or cut, dried leaf of Cynara cardunculus L. (syn. C. Scolymus L.)minimum 0.8 per cent of chlorogenic acid (C16H18O9 ; Mr 354.3) (dried drug).Traditional herbal medicinal product for the
symptomatic relief of digestive disorders such as
dyspepsia with a sensation of fullness, bloating
and flatulence.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Treatment of digestive complaints (e.g. dyspepsia, feeling of fullness, flatulence,
nausea, stomach ache and vomiting). Adjunct treatment
of mild to moderate hypercholesterolaemia. Orally for the treatment of atherosclerosis and kidney dysfunctions (diuretic).
One study has indicated that the crude drug may be of benefit for the
treatment of irritable bowel syndrome, but further randomized controlled
clinical trials are needed before any therapeutic recommendations
can be made.
Oral treatment of anaemia, diabetes, fever, gout, rheumatism and urinary
stones
Digestive complaints (e.g. Stomach ache, nausea, vomiting, feeling of fullness, flatulence) and hepatobiliary disturbances [11-17]. Adjuvant to a low fat diet in the treatment of mild to moderate hyperlipidaemia [12-15, 18-22]1. Source of artichoke leaf and if its solution for hypercholesterolaemia (Wider, 2013)(28) 2. Does dietary supplement with plant extracts imporve the hypercholesterolaemia? (Barrat,2013)(26) 3. A trial that studies if the artichoke leaf extract supplementation have beneffits on HDL-cholesterol patients (Rondanelli, 2013)(27)
Artichoke leaf dry extract (Cynarae folii extractum siccum) 01/2010:2389Dry extract produced from Artichoke leaf (1866).minimum 0.6 per cent of chlorogenic acid (C16H18O9 ; Mr 354.3) (dried extract).
Ash Leaf (Fraxini folium) 07/2012:1600Dried leaf of Fraxinus excelsior L. or Fraxinus angustifolia Vahl (syn. Fraxinus oxyphylla M. Bieb) or of hybrids of these 2 species or of a mixture.minimum 2.5 per cent of total hydroxycinnamic acid derivatives, expressed as chlorogenic acid (C16H18O9 ; Mr 354.3) (dried drug).Indication 1) Traditional herbal medicinal product used for relief of minor articular pain. Indication 2) Traditional herbal medicinal product used to
increase the amount of urine to achieve flushing
of the urinary tract as an adjuvant in minor
urinary complaints.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
1. A study of Hymenoscyphus pseudoalbidus and its effect on Fraxinus excelsior and Fraxinus angustifolia en Europe, lethal disease known as ash dieback (Gross, 2014)(30) 2. A study about the suitability of re-fused tea as a litter material for broiler chickens.(Atapattu, 2007)(29)
Astragalus Monghalicus Root (Astragali mongholici radix) 01/2011:2435Whole, dried root of Astragalus mongholicus var. mongholicus (syn. Astragalus membranaceus Bunge var. mongholicus (Bunge) P.K. Hsiao) and Astragalus mongholicus var. dahuricus (DC.) Podlech (syn. Astragalus membranaceus Bunge),minimum 0.040 per cent of astragaloside IV (C41H68O14 ; Mr 785) (dried drug).NoneAs adjunctive therapy in the treatment of colds and influenza . The herb is used to enhance the immune system and to increase stamina and endurance. Also in the treatment of chronic diarrhoea, oedema, abnormal uterine bleeding, and diabetes mellitus, and as a cardiotonic agent. Treatment of nephritis, chronic bronchitis, postpartum urine retention, leprosy, and the sequelae of cerebrovascular accidents.1. Astralagus as acomponent of an additional treatment to conventional theraphies on chronic kidney disease (Zhang, 2014)(32) 2. The use of Astragalus in Chinese medicine ad its application in phytochemistry (Li, 2014)(31)
Atractylodes Lancea Rhizome (Atractylodis Lancea rhizoma) 07/2012:2559Dried, whole or fragmented rhizome of Atractylodes lancea (Thunb.) DC. (syn. Atractylodes chinensis (Bunge) Koidz.)minimum 14 mL/kg of essential oil (anhydrous drug).1. The treatment of XYS on patients that suffer depression imporved their symptoms (Tian, 2014)(33) 2. Study of the regulatory functions of the active components of traditional chinese medicine and to explain the effects of their decoctions on antioxidant activity and lipid peroxide content (Guo, 2011)(34) 3. Study of the astragalus on patients with osteoporosis (Gao, 2013)(35-37) 4. A review about a medicine and its effect on Colerectal cancer (Chen, 2014)(36)
Atractylodes Rhizome, Largehead (Atractylodis macrocephalae rhizoma) 07/2012:2560Dried, whole or fragmented rhizome of Atractylodes macrocephala Koidz.minimum 9 mL/kg of essential oil (anhydrous drug).1. Study of young woman with leukorrhagia and the effect of toki-shaluyaku-san on them (Sakamoto, 1996)(38) 2. Provement ofhoushiheisan compound on portecting brain units after a celebral ischemia (Wang, 2014)(39) 3. Study of a chinese recipe with lamivudine on patients with hepatitis B and compensated liver cirrhosis (Zhou, 2011)(40)
Aucklandia root (Aucklandiae radix) 04/2016:1797Whole or fragmented dried root of Saussurea costus (Falc.) Lipsch. (syn. Saussurea lappa C.B.Clarke, Aucklandia lappa Decne., Aucklandia costus Falc.)minimum 0.6 per cent of costunolide (C15H20O2 ;
Mr 232.3) and minimum 1.8 per cent for the sum of costunolide and dehydrocostus lactone (C15H18O2 ; Mr 230.3) (dried drug).
Baical Skullcap Root (Scutellariae baicalensis radix) 04/2011:2438Dried, peeled, usually fragmented root of Scutellaria baicalensis Georgi without rootlets.not less than 9.0 per cent of baicalin (C21H18O11 ; Mr 446.4) (dried drug).None. Although clinical case reports suggest that Radix Scutellariae may
stimulate the immune system and induce haematopoiesis, data
from controlled clinical trials are lacking. Treatment of fever, nausea and vomiting, acute dysentery, jaundice,
coughs, carbuncles and sores, and threatened abortion
Treatment of allergies, arteriosclerosis, diarrhoea, dermatitis and hypertension
1. A clinical trial about a medicinal food (flavocoxid) to moderate the knee osteoarthritis (Morgan, 2009)(43) 2. A study about baical skullcap root and its function on pancreatic and gastrointestinal malignancies (Saif, 2010)(45) 3. The effect of Baical skullcap' extract in leukemia young patients (Orzechowska, 2014)(44) 4. Doses of Baical skullcap in healthy subjects: pros and cons (Li, 2014)(42) 5. Results of a combination of herbal drugs on the treatment of the joint discomfort associated with osteoarthritis of the knee (Arjmandi, 2014)(41)
Barbary Wolfberry Fruit (Lycii fructus) 04/2015:2612Dried, whole, ripe fruit of Lycium barbarum L.1. Application of traditional chinese medicine on bones' rats with simulated weightlessness (Zhu, 2013)(47) 2. Clinical trial, study of how fast plasma zeaxanthin responds to Wolfberry is(Cheng, 2005)(46)
Bearberry Leaf (Uvae ursi folium) 07/2013:1054Whole or fragmented, dried leaf of Arctostaphylos uva-ursi (L.) Spreng.Traditional herbal medicinal product used for
treatment of symptoms of mild recurrent lower
urinary tract infections such as burning sensation
during urination and/or frequent urination in
women, after serious conditions have been
excluded by a medical doctor.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
NoneInternally, as a mild urinary antiseptic for moderate inflammatory conditions of the urinary tract and bladder, such as cystitis, urethritis and dysuria. As a diuretic, to stimulate uterine contractions, and to treat diabetes, poor eyesight, renal or urinary calculi, rheumatism and venereal disease. Topical applications have been used for skin depigmentationUncomplicated infections of the lower urinary tract [Frohne 1970; Kedzia 1975; Bradley 1992; Wichtl 1999; Fintelmann 2009; Blaschek 2009; Schilche 2010] such as cystitis, when antibiotic treatment is not considered essential [Coe 1989; Furrer 1994; Weber 1995]1. Study of the urin after administrating Bearberry leaf extract on healthy humans. (Schindler, 2002)(49) 2. Discussion about the risk of a treatment based on Bearberry leaf (de Arriba, 2013)(48) 3. Clinical trial about botanical medicines for the urinary tract(Yarnell, 2002)(50)
Belamcanda Chinensis rhizome (Belamcandae chinensis rhizoma) 01/2014:2561Dried, whole or fragmented rhizome of Iris domestica (L.) Goldblatt et Mabb. (syn. Belamcanda chinensis (L.) DC.),minimum 0.10 per cent of irisflorentin (C20H18O8 ; Mr 386.4) (dried drug).1. Review about Bleamcanda Chinensis and find uses (Zhang, 2016)(52) 2. Review about the Belamcanda chinensis and its description on biactivity and phytochemistry (Woźniak, 2015) (51)
Belladonna Leaf (Belladonnae folium) 01/2012:0221Dried leaf and flowering and occasionally fruit-bearing, tops of Atropa belladonna L.minimum 0.30 per cent of total alkaloids, expressed as hyoscyamine (C17H23NO3 ; Mr 289.4) (dried drug). The alkaloids consist mainly of hyoscyamine together with small quantities of hyoscine (scopolamine).1. Review of a case about a seizure caused by an ingestion of Atropa Belladonna (Glatstein, 2014)(53)
Belladonna leaf dry extract, standardised (Belladonnae folii extractum siccum normatum) 07/2015:1294Standardised dry extract obtained from Belladonna leaf (0221).0.95 per cent to 1.05 per cent of total alkaloids, expressed as hyoscyamine (C17H23NO3 ; Mr 289.4) (dried extract).
Belladonna leaf tincture, standardised (Belladonnae folii tinctura normata) 01/2011:1812Tincture produced from Belladonna leaf (0221).0.027 per cent to 0.033 per cent of total alkaloids, calculated as hyoscyamine (C17H23NO3 ; Mr 289.4). The alkaloids consist mainly of hyoscyamine together with small quantities of hyoscine.
Belladonna, Prepared (Belladonnae pulvis normatus) 01/2008:0222Belladonna leaf powder (180) adjusted, if necessary,
by adding powdered lactose or belladonna leaf powder with a lower alkaloidal content.
0.28 per cent to 0.32 per cent of total alkaloids, expressed as hyoscyamine (Mr 289.4) (dried drug).
Benzoin, Siam (Benzoe tonkinensis) 01/2016:2158Resin obtained by incising the trunk of Styrax tonkinensis (Pierre) Craib ex Hartwich.35.0 per cent to 55.0 per cent of total acids, expressed as benzoic acid (C7H6O2 ; Mr 122.1) (dried drug).
Benzoin, Sumatra (Benzoe sumatranus) 01/2008:1814Resin obtained by incising the trunk of Styrax benzoin Dryander.25.0 per cent to 50.0 per cent of total acids, calculated as benzoic acid (C7H6O2 ; Mr 122.1) (dried drug).
Benzoin tincture, Siam (Benzois tonkinensis tinctura) 01/2008:2157Tincture produced from Siam benzoin (2158).minimum 5.0 per cent m/m of total acids, calculated as benzoic acid (C7H6O2 ; Mr 122.1).
Benzoin tincture, Sumatra (Benzois sumatrani tinctura) 01/2008:1813Tincture produced from Sumatra benzoin (1814).minimum 4.0 per cent m/m of total acids, calculated as benzoic acid (C7H6O2 ; Mr 122.1).
Bilberry Fruit, Dried (Myrtilli fructus siccus) 01/2016:1588Dried ripe fruit of Vaccinium myrtillus L.minimum 1-0 per cent of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1) (dried drug).Indication 1)
Traditional herbal medicinal product for
symptomatic treatment of mild diarrhoea. Indication 2)
Traditional herbal medicinal product for
symptomatic treatment of minor inflammations
of the oral mucosa.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Oral use for the symptomatic treatment of dysmenorrhoea associated
with premenstrual syndrome, circulatory disorders in patients with
capillary leakage or peripheral vascular insufficiency and ophthalmic
disorders. Oral use for the treatment of acute diarrhoea and local irritation or in-
flammation of the mucous membranes of the mouth and throat
Treatment of capillary fragility, diarrhoea, eye disorders, haemorrhoids,
intestinal disorders, skin disorders and venous insufficiency. Also used as
a diuretic
Supportive treatment of acute non-specific diarrhoea. In this indication the efficacy is plausible due to long-standing use [Schilcher 1997;]
Bilberry Fruit, Fresh (Myrtilli fructus recens) 01/2016:1602Fresh or frozen, ripe fruit of Vaccinium myrtillus L.minimum 0.30 per cent of anthocyanins, expressed as cyanidin 3-O-glucoside chloride (chrysanthemin, C21H21ClO11 ; Mr 484.8) (dried drug).Indication 1)
Traditional herbal medicinal product to relieve
symptoms of discomfort and heaviness of legs
related to minor venous circulatory disturbances.
Indication 2)
Traditional herbal medicinal product to relieve
symptoms of cutaneous capillary fragility.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Oral use for the symptomatic treatment of dysmenorrhoea associated
with premenstrual syndrome, circulatory disorders in patients with
capillary leakage or peripheral vascular insufficiency and ophthalmic
disorders. Oral use for the treatment of acute diarrhoea and local irritation or in-
flammation of the mucous membranes of the mouth and throat
Treatment of capillary fragility, diarrhoea, eye disorders, haemorrhoids,
intestinal disorders, skin disorders and venous insufficiency. Also used as
a diuretic
(Extracts riched with anthocyanins) Supportive treatment of problems related to varicose veins such as painful and heavy legs, peripheral vascular insifficiency & microcirculatory disorders of the eye [Ghiringhelli 1978; Passariello 1979; Grismondi 1980; Tori 1980; Nuti 1980; Scharrer 1981; Allegra 1982; Signorini 1983a; Signorini 1983b; Corsi 1985; Gatta 1988; Morazzoni 1996]1. Study if Bilberry' ingestion improves to moderate ulcerative colitis (Biedermann, 2013)(55) 2. Clinical trial discussion: discriminates a diet-specific that involves a consuption bilberries and many other specific food (Hanhineva, 2015)(56) 3. Clinical trial study: Does polyphenol-rich juice reduce blood preassure? (Tjelle, 2015)(57) 4. Study about if bilberry reduce postprandial insulin responses to wheat and rye breads (in healthy women) (Törrönen, 2013)(58) 5. Review on recent advances about anti-diabetic actions of dietary flavonoids (Babu, 2013)(54)
Birch Leaf (Betulae folium) 01/2017:1174Whole or fragmented, dried leaves of Betula pendula Roth and/or Betula pubescens Ehrh.minimum 1.5 per cent of flavonoids, expressed as hyperoside (C21H20O12 ; Mr 464.4) (dried drug).Traditional herbal medicinal product to increase
the amount of urine to achieve flushing of the
urinary tract as an adjuvant in minor urinary
complaints.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Irrigation of the urinary tract, especially in cases of inflammation and renal gravel, and as an adjuvant in the treatment of bacterial infections of the urinary1. Proof of herbal medicines against urinary tract infections (Bastigkeit, 2015)(59) 2. Meta-analysis study about the damage and herbivore abundace on tree species (Vehviläinen, 2007) (60)
Bistort rhizome (Bistortae rhizoma) 01/2017:2384Whole of fragmented, dried rhizome of Persicaria bistorta (L.) Samp. (syn. Polygonum bistorta L.) without adventitious roots.minimum 3.0 per cent of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1) (dried drug).
Bitter-fennel fruit oil (Foeniculi amari fructus aetheroleum) 01/2008:1826Essential oil obtained by steam distillation from the ripe fruits of Foeniculum vulgare Miller, ssp. vulgare var. vulgare.– fenchone: 12.0 per cent to 25.0 per cent,
– trans-anethole: 55.0 per cent to 75.0 per cent
Traditional herbal medicinal product used as an expectorant in cough associated with cold. The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.None.Symptomatic treatment of dyspepsia, bloating and fl atulence.
As an expectorant for mild infl ammation of the upper respiratory tract. Treatment of pain in scrotal hernia, and dysmenorrhoea. Treatment of blepharitis, bronchitis, constipation, conjunctivitis, diabetes,
diarrhoea, dyspnoea, fever, gastritis, headache, pain, poor appetite and
respiratory and urinary tract infections. As an aphrodisiac, anthelminthic,
emmenagogue, galactagogue and vermicide
Bitter-fennel herb oil (Foeniculi amari herbae aetheroleum) 07/2009:2380Essential oil obtained by steam distillation of the aerial parts of Foeniculum vulgare Mill. ssp. vulgare, var. vulgare collected during fruiting.
Bitter orange Flower (Aurantii amari flos) 01/2012:1810Whole, dried, unopened flower of Citrus aurantium L. ssp. aurantium (C. aurantium L. ssp. amara Engl.)minimum 8.0 per cent of total flavonoids, expressed as naringin (C27H32O14 ; Mr 580.5) (dried drug).1. Study about the application of dannang recipe n. 2 in the perioperative of laparoscopic cholecystectomy (Xu, 2008)(61)
Bitter-orange epicarp and mesocarp (Aurantii amari epicarpium et mesocarpium) 07/2015:1603Dried epicarp and mesocarp of the ripe fruit of Citrus aurantium L. ssp. aurantium (C. aurantium L. ssp. amara Engl.)minimum 20 mL/kg of essential oil (anhydrous drug).
Black Cohosh (Cimicifugae rhizoma) 04/2014:2069Dried, whole or fragmented rhizome and root of Actaea racemosa L. (syn. Cimicifuga racemosa (L.) Nutt.).minimum 1.0 per cent of triterpene glycosides, expressed as monoammonium glycyrrhizate (C42H65NO16 ; Mr 840) (dried drug).__Herbal medicinal product for the relief of
menopausal complaints such as hot flushes and
profuse sweating
Treatment of climacteric symptoms such as hot flushes, profuse sweating, sleeping disorders and nervous irritabilityTreatment of premenstrual syndrome and dysmenorrhoea. Treatment of coughs, dyspepsia, epilepsy, intercostal myalgia, rheumatoid arthritis, sciatica, snake bites, tinnitus and whooping coughClimacteric symptoms such as hot flushes, profuse sweating sleep disorders and nervous irritability [Osmers 2005, Bai 2007, Nappi 2005, Wuttke 2003b, Hernández Muñoz 2003, Kaiser 2008, Frei-Kleiner 2005, Oktem 2007].1. Comparation on different treatments on prostate or breats cancer' patients (Hutton, 2015) (62) 2. Clinical trial about studies on Cimicifuga racemosa and its effects on menospausal symptoms (Tanmahasamut, 2015)(66) 3. The stability that has black cohosh on triterpene glycosides and polyphenols (Jiang, 2013)(63) 4. Study about black cohosh and efficacy on menopausal symptoms (Leach, 2012)(64) 5. Meta-analysis about black cohosh and its efficacy onmenopausal symptoms (Shams, --)(65)
Black Horehound (Ballotae nigrae herba) 07/2011:1858Dried flowering tops of Ballota nigra L.minimum 1.5 per cent of total ortho- dihydroxycinnamic acid derivatives, expressed as acteoside (C29H36O15 ; Mr 625) (dried drug).
Blackcurrant Leaf (Ribis nigri folium) 07/2013:2528Dried leaf of Ribes nigrum L.minimum 1.0 per cent of flavonoids, expressed as
isoquercitroside (C21H20O12 ; Mr 464.4) (dried drug).
Indication 1) Traditional herbal medicinal product for relief of minor articular pain. Indication 2) Traditional herbal medicinal product to increase the amount of urine to achieve flushing of theurinary tract as an adjuvant in minor urinary
complaints.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Adjuvant in the treatment of rheumatic conditions [11-16]1. Discussion about blackcurrant products and results on microbiota and markers of risk for colon cancer in humans (Molan, 2014)(68) 2. Study about the alternative of bioactive natual products of nutritional and medicine value (Ferlemi, 2016) (67)
Bladderwrack (Fucus vesiculosus, thallus)Traditional herbal medicinal product used as an
adjuvant to reduced calorie diet to help weight
loss in overweight adults, after serious conditions
have been excluded by a medical doctor.
The product is a traditional herbal medicinal
product for use in the specified indication exclusively based upon long-standing use.
1. A new finding about the efficacy on a synbiotic drink, chronic diseases of gastrointestinal tract and concomitant dysbacteriosis patients (Kuznetsova, 2013)(69) 2. Study on anticancer effect of Bladderwrack and seaweed (Moussavou, 2014)(70) 3. Effect of a seaweed, capable of having effects on mentrual cycle lenght and hormonal status in three pre-menstrual women (Skibola, 2004)(71)
Bogbean Leaf (Menyanthidis trifoliatae folium) 01/2008:1605Dried, entire or fragmented leaf of Menyanthes trifoliata L.Iridoid glycosides -approx. 1% of bitter substances including the iridoid loganin and the seco-iridoids foliamenthin dihydrofoliamenthin, mentjiaafolin and sweroside. Maximum concentrations of bitter substances were recorded during flower-bud initiation [...]As a bitter [BHP 1996, Bruneton 1999] in loss of appetite, peptic discomfort and a atonic dyspepsia [Schilcher 2007], as well as for gall bladder and biliary tract disorders [Sweetman 2007]
Boldo Leaf (Boldi folium) 04/2016:1396Whole or fragmented dried leaf of Peumus boldus Molina.minimum 0.1 per cent of total alkaloids, expressed
as boldine (C19H21NO4 ; Mr 327.4) (anhydrous drug).
Traditional herbal medicinal product for symptomatic relief of dyspepsia and mild spasmodic disorders of the gastrointestinal tract. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
Boldo leaf dry extract (Boldi folii extractum siccum) 04/2016:1816Extract produced from Boldo leaf (1396).– for aqueous extracts: minimum 0.1 per cent of total alkaloids, expressed as boldine (C19H21NO4 ; Mr 327.4) (anhydrous extract);
– for hydroalcoholic extracts: minimum 0.2 per cent of total alkaloids, expressed as boldine (C H NO ; M 327.4) (anhydrous extract).
Buckwheat Herb (Fayopyri herba) 07/2013:2184Whole or fragmented aerial parts of Fagopyrum esculentum
Moench, collected in the early flowering period prior to fruiting and dried immediately.
minimum 3.0 per cent of rutin (C27H30O16 ; Mr 611) (dried drug)1. Buckwheat herb effect on patients with chronic venous insufficiency (Ihme, 1996) (72)
Burdock Root (Arctii radix)Indication 1)
Traditional herbal medicinal product used to
increase the amount of urine to achieve flushing
of the urinary tract as an adjuvant in minor
urinary tract complaints.
Indication 2)
Traditional herbal medicinal product used in
temporary loss of appetite.
Indication 3)
Traditional herbal medicinal product used in
treatment of seborrhoeic skin conditions.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
1. A review Burdork root and effects (Chan, 2011)(73) 2. Cliniclal observation on diabetic nephropathy patients' treatment (Wang, 2004)(74)
Butcher's broom (Rusci rhizoma) 01/2017:1847Dried, whole or fragmented underground parts of Ruscus aculeatus L.minimum 1.0 per cent of total sapogenins, expressed as ruscogenins [mixture of neoruscogenin (C27H40O4 ;
Mr 428.6) and ruscogenin (C27H42O4 ; Mr 430.6)] (dried drug)
a) Traditional herbal medicinal product to
relieve symptoms of discomfort and
heaviness of legs related to minor venous
circulatory disturbances
b) Traditional herbal medicinal product for
symptomatic relief of itching and burning
associated with haemorrhoids.
The product is a traditional herbal medicinal
product for use in specified indication exclusively
based upon long-standing use.
1. A study about butcher's broom and use. (Vansheidt, 2002) (75)
Calendula Flower (Calendulae flos) 01/2011:1297Whole or cut, dried, and fully opened flowers that have been detached from the receptacle of the cultivated, double-flowered varieties of Calendula officinalis L.minimum 0.4 per cent of flavonoids, expressed as hyperoside (C21H20O12 ; Mr 464.4) (dried drug).a) Traditional herbal medicinal product for the
symptomatic treatment of minor
inflammations of the skin (such as sunburn)
and as an aid in healing of minor wounds.
b) Traditional herbal medicinal product for the
symptomatic treatment of minor
inflammations in the mouth or the throat.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
NoneExternal treatment of superficial cuts, minor inflammations of the skin and oral mucosa, wounds and ulcus cruris. Treatment of amenorrhoea, angina, fevers, gastritis, hypotension, jaundice, rheumatism and vomiting1. Efficacy of calendula flower on diaper dermatitis in children (Panahi, 2012)(79) 2. Report of calendula officinalis on derived cosmetic ingredients (Andersen, 2010)(77) 3. Discussion of different propylene glycol extracts of Calendular officinalis (Frankic, 2009)(78)
California poppy (Eschsholziae herba)1) Traditional herbal medicinal product for relief of
mild symptoms of mental stress.
2) Traditional herbal medicinal product to aid
sleep.
The product is a traditional herbal medicinal
product for use in specified indications exclusively based upon long-standing use.
Cape Jasmine Fruit (Gardeniae fructus) 01/2017:2565Whole or fragmented, ripe fruit of Gardenia jasminoides J.Ellis, with stalk removed, steamed or treated with boiling water, then dried.minimum 2.0 per cent of geniposide (C17H24O10 ; Mr 388.4) (dried drug).
Capsicum (Capsici Fructus) 01/2014:1859Dried ripe fruits of Capsicum annuum L. var. minimum (Miller) Heiser and small-fruited varieties of Capsicum frutescens L.minimum 0.4 per cent of total capsaicinoids, expressed as capsaicin (C18H27NO3 ; Mr 305.4) (dried drug).Herbal medicinal product for the relief of muscle
pain such as low back pain.
Herbal medicinal product for the relief of muscle
pain such as low back pain.
1. Study on gene expression (ileal mucosa in weaned pigs) and the effect that have capsicum (and more) on it. (Liu, 2014)(84) 2. Use of Capsium as a suppliment in young boiler chickens (Lee, 2013)(83) 3. Study of Capsicum and the effect on increase intestinal microbiome and necrotic enteritis (Kim, 2015)(82) 4. Mixture of herbal drugs, and effect on imporvement energy utilization and growth of broiler chickens (Bravo, 2014)(80) 5. Herbal medicine for low back pain (Gagnier, 2016) (81)
Capsicum oleoresin, refined and standardised (Capsici oleoresina raffinata et normata) 01/2014:2336Refined and standardised oleoresin produced from Capsicum (1859).12.0 per cent to 18.0 per cent m/m of total capsaicinoids, expressed as capsaicin (C18H27NO3 ; Mr 305.4).
Capsicum soft extract, Standardised (Capsici extractum spissum normatum) 01/2014:2529Standardised soft extract produced from Capsicum (1859).2.0 per cent to 2.4 per cent of total capsaicinoids, expressed as capsaicin (C18H27NO3 ; Mr 305.4).
Capsicum tincture, Standardised (Capsici tinctura normata) 01/2014:2337Standardised tincture produced from Capsicum (1859) or Refined and standardised capsicum oleoresin (2336).90 per cent to 110 per cent of the nominal content of total capsaicinoids, expressed as capsaicin (C18H27NO3 ; Mr 305.4), stated on the label, which is between 0.020 per cent m/m and 0.060 per cent m/m.
Caraway Fruit (Carvi fructus) 01/2008:1080Whole, dry mericarp of Carum carvi L.minimum 30 mL/kg of essential oil (anhydrous drug).Traditional herbal medicinal product for the
symptomatic relief of digestive disorders such as
bloating and flatulence.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
1. Modificaction of the preparation for functional dyspepsia (Madisch, 2001)(87) 2. Prerequisites in pharmaceutical field for a multi-target theraphy (Kroll, 2006)(86) 3. Effects of caraway extract (Kazemipoor, 2014) (85)
Caraway oil (Carvi aetheroleum)Oil obtained by steam distillation from the dry fruits of
Carum carvi L.
Traditional herbal medicinal product for the
symptomatic relief of digestive disorders such as bloating and flatulance. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.
1. Effects of caraway extract (Kazemipoor, 2014) (88)
Cascara (Rhamni purshianae cortex) 04/2011:0105Dried, whole or fragmented bark of Rhamnus purshiana DC. (syn. Frangula purshiana (DC.) A.Gray).minimum 8.0 per cent of hydroxyanthracene glycosides of which minimum 60 per cent consists of cascarosides, both expressed as cascaroside A (C27H32O14 ; Mr 580.5) (dried drug)Herbal medicinal product for short-term use in
cases of occasional constipation.
Short-term treatment of occasional constipationAs a cathartic. Internally for treatment of diabetes and externally for skin irritations1. A supplement work as an alternative to laxatives (Khaja, 2005)(90) 2. Cascara as a treatment for constipation (Cirillo, 2015)(89) 3. The use of oral cathartics to improve the gallium scan (Silberstein, 1981) (91)
Cascara dry extract, standardised (Rhammi purshianae extractum siccum normatum) 01/2008:1844Standardised dry extract obtained from Cascara (0105).90 per cent to 110 per cent of the nominal content
of hydroxyanthracene glycosides, expressed as cascaroside A
(C H O ; M 580.5), minimum 60 per cent of the hydroxyanthracene glycosides are cascarosides, expressed as cascaroside A
Cassia oil (Cinnamoni cassiae aetheroleum) 01/2008:1496Essential oil obtained by steam distillation of the leaves and
young branches of Cinnamomum cassia Blume (C. aromaticum Nees).
Castor oil (Ricini oleum)Short-term treatment (3–5 days) for acute constipation when other dietary
methods or bulk-forming laxatives have not provided adequate relief.
As a cathartic for use in bowel evacuation prior to surgery. Used
externally for topical dermatoses and dermatitis
Used as an emmenagogue, to induce labour, for the treatment of burns,
bronchitis, diarrhoea, itching, earache, haemorrhoids, pneumonia, rheumatism
and sprains
1. Use of castoroil for cervical priming and induction of labous (Kelly, 2013)(93) 2. Use of substance in castor oil for application in advanced cancer patients (Slingerland, 2013)(94) 3. Study in broiler finisher and its response of castor oil beans (Ani, 2009) (92)
Centaury (Centaurii herba) 01:2008/1301Whole or fragmented dried flowering aerial parts of Centaurium erythraea Rafn s. l. including C. majus (H. et L.) Zeltner and C. suffruticosum (Griseb.) Ronn. (syn.: Erythraea centaurium Persoon ; C. umbellatum Gilibert ; C. minus Gars.).Traditional herbal medicinal product used in mild
dyspeptic/gastrointestinal disorders and in
temporary loss of appetite.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Dyspeptic complaints; lack of appetite [3, 25-28]
Centella (Centellae asiaticae herba) 01/2016:1498Dried, fragmented aerial parts of Centella asiatica (L.) Urban.minimum 6.0 per cent of total triterpenoid derivatives, expressed as asiaticoside (C48H78O19 ; Mr 959.15) (dried drug).Treatment of wounds, burns, and ulcerous skin ailments, and prevention of keloid and hypertrophic scars. Extracts of the plant have been employed to treat second- and third-degree burns . Extracts have been used topically to accelerate healing, particularly in cases of chronic postsurgical and post-trauma wounds. Extracts have been administered orally to treat stressinduced stomach and duodenal ulcersHerba Centellae is reported to be used in the treatment of leprous ulcers and venous disorders.
Studies suggest that extracts of Centella asiatica cause regression of inflammatory infiltration of the liver in cirrhosis patients Further experimentation is needed to confirm these findings. Therapy of albinism, anaemia, asthma, bronchitis, cellulite, cholera, measles, constipation, dermatitis, diarrhoea, dizziness, dysentery, dysmenorrhoea, dysuria, epistaxis, epilepsy, haematemesis, haemorrhoids, hepatitis, hypertension, jaundice, leukorrhoea, nephritis, nervous disorders, neuralgia, rheumatism, smallpox, syphilis, toothache, urethritis, and varices; and as an antipyretic, analgesic, anti-inflammatory, and "brain tonic" agent . Poultices have been used to treat contusions, closed fractures, sprains, and furunculosis""erba Centellae is reported to be used in the treatment of leprous ulcers and venous disorders.
Studies suggest"1. Study about the mood-change with administration of Centella (Wattanathorn, 2008)(95) 2. Treatment with patients that have macular edema without macular thickening, oral administration of Centella apart of other substances. (Forte, 2013)(97) 3.The application of phelebotonic for venous insufficiency (Martinez-Zapata, 2016)(96) 4. Review about how plants can have effect on osteogenic differentation and mineralization of periodontal ligament cells (Costa, 2016)(98)
Chamomile Flower, Roman (Chamomillae romanae flos) 01/2017:0380Dried flower-heads of the cultivated double variety of
Chamaemelum nobile (L.) All. (Anthemis nobilis L.).
minimum 7 mL/kg of essential oil (dried drug).Traditional herbal medicinal product for the
symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and
flatulence.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Internal use
Symptomatic treatment of digestive ailments such as dyspepsia, epigastric bloating, impaired digestion, and flatulence. Infusions of camomile flowers have been used in the treatment of restlessness and in mild cases of insomnia due to nervous disorders. External use: Inflammation and irritations of the skin and mucosa (skin cracks, bruises, frostbite, and insect bites) , including irritations and infections of the mouth and gums, and haemorrhoids. Inhalation: Symptomatic relief of irritations of the respiratory tract due to the common cold
Adjuvant in the treatment of minor inflammatory conditions of the gastrointestinal tract. As an antibacterial and antiviral agent, an emetic, and an emmenagogue. It is also used to relieve eye strain, and to treat urinary infections and diarrhoea1. Phytotherapy for indigestion (Rösch, 2006)(100) 2. The safety use of Chamomille and its efficacy for knee osteoarthritis (Shoara, 2015)(99) 3. Centuary as a supplement for dysmenorrhoea (Pattanittum, 2016)(101) 4. Study about decresing the gingival bleeding with chamomille and pomegranate extracts by mouth rising (Batista, 2014)(103) 5. Study about interventing nausea and vomiting in (early) pregancy (Matthews, 2015) (102)
Cinchona Bark (Cinchonae cortex) 01/2011:0174Whole or cut, dried bark of Cinchona pubescens Vahl (Cinchona succirubra Pav.), of Cinchona calisaya Wedd., of Cinchona ledgeriana Moens ex Trimen, or of their varieties or hybrids.minimum 6.5 per cent of total alkaloids, of which 30 per cent to 60 per cent consists of quinine-type alkaloids (dried drug).1. Study about cinchona' structure (Boratyński, 2015)(105)
Cinchona liquid extract, Standardised (Cinchonae extractum fluidum normatum) 01/2008:1818Liquid extract produced from Cinchona bark (0174).minimum 4.0 per cent and maximum 5.0 per cent of total alkaloids, of which 30 per cent to 60 per cent are alkaloids of the quinine type (C20H24N2O2 ; Mr 324.4).
Cinnamon (Cinnamomi cortex) 04/2011:0387Dried bark, freed from the outer cork and the underlying parenchyma, of the shoots grown on cut stock of Cinnamomum verum J.Presl.minimum 12 mL/kg of essential oil.Indication 1
Traditional herbal medicinal product for
symptomatic treatment of mild, spasmodic gastrointestinal
complaints including bloating and
flatulence.
Indication 2
Traditional herbal medicinal product for
symptomatic treatment of mild diarrhoea.
The product is a traditional herbal medicinal
product for use in a specified indications
exclusively based upon long-standing use.
NoneThe treatment of dyspeptic conditions such as mild spastic conditions of the gastrointestinal tract, fullness and flatulence, and loss of appetite . Also used to treat abdominal pain with diarrhoea, and pain associated with amenorrhoea and dysmenorrhoea. The treatment of impotence, frigidity, dyspnoea, inflammation of the eye, leukorrhoea, vaginitis, rheumatism, neuralgia, wounds, and toothache1. Turmeric and his improving in pre-diabetics and his before-meal working (Lee, 2014)(106) 2. Cinnamon effects on glucose and lipid controls (Baker, 2008)(109) 3. The use of Cinnamon on two different diabetes (Allen, 2013)(110) 4. Ingesting cinnamon can slow down fasting blood glucose? (Davis, 2011)(107) 5. Cinnamon and his effect that have before meals ingestion, connected with glucose concentration (Bernardo, 2015)(108)
Cinnamon bark oil, Ceylon (Cinnamomi zeylanici corticis aetheroleum) 04/2011:1501Essential oil obtained by steam distillation of the bark of the shoots of Cinnamomum verum J.Presl.Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastrointestinal complaints including bloating and flatulence. The product is a traditional herbal medicinal product for use in a specified indicationexclusively based upon long-standing use.
Cinnamon leaf oil, Ceylon (Cinnamomi zeylanici folii aetheroleum) 01/2008:1608Oil obtained by steam distillation of the leaves of
Cinnamomum verum J.S. Presl.
Cinnamon tincture (Cinnamomi corticis tinctura) 01/2008:1819Tincture produced from Cinnamon (0387).
Citronella oil (Citronellae aetheroleum) 01/2008:1609Oil obtained by steam distillation from the fresh or partially dried aerial parts of Cymbopogon winterianus Jowitt.
Clary sage oil (Salvae sclareae aetheroleum) 01/2008:1850Essential oil obtained by steam distillation from the fresh or
dried flowering stems of Salvia sclarea L.
Clematis Armandii Stem (Clematidis armandii caulis) 04/2013:2464Whole or fragmented, dried stem of Clematis armandii Franch., with cork removed.minimum 0.30 per cent of oleanolic acid (C30H48O3 ; Mr 456.7) (dried drug).
Clove (Caryophylli flos) 01/2008:0376Whole flower buds of Syzygium aromaticum (L.) Merr. et L.M.Perry (syn. Eugenia caryophyllus (Spreng.) Bullock et S.G.Harrison) dried until they become reddish-brown.minimum 150 mL/kg of essential oil.NoneExternal or local applications for the treatment of toothache, and minor infections of the mouth and skin. Also used as an antiseptic for dressing of minor wounds, and, in the form of lozenges, for sore throats and coughs associated with the common cold. The essential oil (1-5%) is used in mouthwashes. Treatment of asthma, bleeding gums, dyspepsia, fevers and morning sickness1. Clove and its productive effect for anal fissure theraphy (Nelson, 2012)(12) 2. Is clove effective for acute external otitits? (Panahi, 2014)(111) 3. Improving oral irritation (with no side effects) with clove (Klein, 2013)(113) 4. Review about clove (in general) (Cortés-Rojas, 2014)(114) 5. Clove and benzocaine as (tropical) anesthetics (Alqareer, 2006)(115)
Clove oil (Caryophylii floris aetheroleum)Essential oil obtained by steam distillation from the dried flower buds of Syzygium aromaticum (L.) Merr. et L.M.Perry (syn. Eugenia caryophyllus (Spreng.) Bullock et S.G.Harrison).Indication 1)
Traditional herbal medicinal product for the
symptomatic treatment of minor inflammations in the mouth or the throat. Indication 2) Traditional herbal medicinal product for the temporary relief of toothache due to a dental cavity. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
In dental healthcare, for short term use, as a local anaesthetic [Leung 1980; Reynolds 1989], as a disinfectant mouthwash [Wichtl 2002; Bradley 2006; Blaschek 2008]. In these treatments the efficacy is plausible on the basis of human experience and longstanding use. Symptomatic treatment in chronic anal fissure, after diagnosis by a physician [Elwakeel 2007]
Codonopsis Root (Codonopsidis radix) 01/2017:2714Whole or fragmented, dried root of Codonopsis pilosula (Franch.)1. Study for Codonopsis and his effect on chronic obstructive pulmonary disease (Shergis, 2015)(116) 2. Chronic neck pain due to cervical degenerative disc disease, chinene herbal medicine (Trinh, 2010)(118) 3. Injection made of shenqifuzheng and his solution treatment afterwards (Ai, 2014)(117) 4. Tretament of operated late gastric carcicoma via chemotheraphy with many herbal plants (Wang, 1990)(119)
Coix Seed (Coicis semen) 01/2013:2454Dried ripe, caryopsis, freed from the shell, of Coix lacryma-jobi L. subsp. ma-yuen (Ron. Caill) T.Koyamaminimum 0.50 per cent of triolein (C57H104O6 ; Mr 885) (dried drug).1. Treatment for advanced colorectal cancer (Chen, 2014) (120)
Cola (Colae semen) 01/2008:1504Whole or fragmented dried seed, feed from the testa, of Cola nitida (Vent. Schott et Endl. (C. Vera K. Schum.) and its varieties, as well as of Cola acuminata (P. Beauv. Schott et Endl., (Sterculia acuminata P. Beauv.).It contains not less tah 1.5 per cent of caffeine (Mr 194.2) (dried drug.)Traditional herbal medicinal product for symptoms
of temporary fatigue and sensation of weakness.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use
For the treatment of short-term physical and/or mental exhaustion. In these indications, the efficacy is plausible on the basis of human experience and long-standing use [Kerharo 1969, Etkin 1981, Bradley 1992]
Colophony (Colophonium) 01/2008:1862Residue remaining after distillation of the volatile oil from the
oleoresin obtained from various species of Pinus.
Comfrey Root (Symphyti radix)Dried rhizomes and roots of Symphytum officinale L.Traditional herbal medicinal product used for the
symptomatic relief of minor sprains and bruises.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Pain and swelling in muscles and joints [Koll 2002; Koll 2004; Tschaikin 2004; Pabst 2004; Predel 2005; Staiger 2007; Grube 2007; Giannetti 2010], osteoarthritis [Grube 2007; Schulz 2007], acute myalgia in the back [Giannetti 2010], strains, contusions and distortions [Koll 2002, Koll 2004, Tschailin 2004, Pabst 2004, Predel 2005, Staiger 2007], epicondylitis, tendovaginitis and periarthritis [Petersen 1993]1. Comfrey root for painful knee osteoarthritis patients (tretament) (Grube, 2007)(123) 2. Acute upper or low back pain can be solved with comfrey root (extract) and methyl nicotine? (Pabst, 2013)(122) 3. Comfrey root extract and its efficacy on acute upper or low back pain (Giannetti, 2010)(124) 4. Compatation between comfrey root and diclofenac gel for ankle distortions treatment (Predel, 2005)(121) 5. Comfrey root for low back pain tretament (Gagnier, 2016)(81)
Common Selfheal Fruit- Spike (Prunellae Spica) 01/2017:2439Dried fruit-spike of Prunella vulgaris L.minimum 0.12 per cent of the sum of oleanolic acid (C30H48O3; Mr 456.7) and ursolic acid (C30H48O3 ; Mr 456.7), expressed as ursolic acid, of which not less than 70.0 per cent consists of ursolic acid (dried drug).1. Breast hyperplasia treated with auricular point sticking theraphy, also with Xiaopijian (Peng, 2015) (125)
Coriander (Coriandri fructus) 07/2014: 1304Dried cremocarp of Coriandrum sativum L.minimum 3 mL/kg of essential oil (dried drug).1. Study of a dietary for reducing phthalate and bisphenol A exposures (Sathynarayana, 2013)(126) 2. Essential oil can work as multifunctional additives in meat amd fis-based food products (Patel, 2015)(127)
Coriander oil (Coriandri aetheroleum) 07/2014:1820Dried cremocarp of Coriandrum sativum L.minimum 3 mL/kg of essential oil (dried drug).
Couch grass rhizome (Graminis rhizoma) 04/2011:1306Whole or cut, washed and dried rhizome of Agropyron repens (L.) P.Beauv. (Elymus repens (L.) Gould); the adventitious roots are removed.Traditional herbal medicinal product to increase
the amount of urine to achieve flushing of the
urinary tract as an adjuvant in minor urinary
complaints.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Irritable bladder and other urinary tract disorders [17, 18]. Efficacy in these indications is plausible on the basis of human experience and long-standing use. [19-22].
Cranberry (Vaccinii macrocarpi fructus)Orally as adjunct therapy for the prevention and symptomatic treatment
of urinary tract infections in adults. Two clinical trials have assessed
the effect of the fruit juice in paediatric populations, but
the results were negative. Results from clinical trials involving the use of
cranberry for the treatment of children with neurogenic bladder were also
negative and do not support the use of cranberry products in paediatric
populations
Treatment of asthma, fever, loss of appetite, scurvy and stomach ailments,
as well as gallbladder and liver disease and for treatment of wounds
1. Probiotics for urinary tract infection (all ages) prevention (Schwenger, 2015)(128) 2. Cranberry for urinary tract infections' prevention (Jepson, 2004) (131) 3. Cranberry and warfarin (coagulant) in pharmacodynamic interaction (Mohammed, 2009)(130) 4. Study about positive effectsof cranberry juice (Novotny, 2015(129) 5. Study about the negative and positive effects that have cranberry juice consumition (Flammer, 2013)(132)
Dandelion Herb with Root (Taraxaci officinalis herba cum radice) 07/2012:1851Mixture of whole or fragmented, dried aerial and underground
parts of Taraxacum officinale F.H. Wigg.
Indication a) Traditional herbal medicinal product for the relief of symptoms related to mild digestive disorders (such as feeling of abdominal fullness, flatulence, and slow digestion) and temporary loss of appetite. Indication b) Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.To stimulate diuresis, increase bile fl ow and stimulate appetite, and
for treatment of dyspepsia
As a galactagogue, laxative and tonic. Treatment of boils and sores, diabetes,
fever, infl ammation of the eye, insomnia, sore throat, lung abscess,
jaundice, rheumatism and urinary tract infections
Dandelion leaf (Taraxaci folium)Traditional herbal medicinal product to increase
the amount of urine to achieve flushing of the
urinary tract as an adjuvant in minor urinary
complaints.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Dandelion root (Taraxaci officinalis radix) 01/2011:1852Whole or cut, dried underground parts of Taraxacum officinale F.H.Wigg.· · ·· · ·Restoration of hepatic and biliary function, dyspepsia, loss of appetite [11, 15]1. Review about dandelion root plant and properties of wild specie (Guarrera, 2013)(133) 2. Effect of inulin (from plants) supplement for blood lipid indices and more test (Grela, 2014)(134)
Devil's claw Root (Harpagophyti radix) 01/2011:1095Cut and dried, tuberous secondary roots of Harpagophytum procumbens DC. And/or Harpagophytum zeyheri Decne.minimum 1.2 per cent of harpagoside (C24H30O11 ; Mr 494.5) (dried drug).a) Traditional herbal medicinal product for relief
of minor articular pain.
b) Traditional herbal medicinal product used for
the relief of mild digestive disorders such as
bloating and flatulence and where there is loss
of appetite.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based on long-standing use.
Treatment of loss of appetite and dyspeptic complaints; supportive treatment
of degenerative rheumatism, painful arthrosis and tendonitis
Treatment of allergies, boils, diabetes, liver disorders and sores.Symptomatic treatment of painful osteoarthritis [10-18] , relief of low back pain [19-23], loss of appetite and dyspepsia [24-30]1. Study about herbs on nephrotoxicity and its mechanisms to intoduce it (Allard, 2013)(135)
Devil's claw, dry extract (Harpagophyti extractum siccum) 01/2008:1871Dry extract obtained from Devil’s claw root (1095).minimum 1.5 per cent of harpagoside (C24H30O11 ; Mr 494.5) (dried extract).
Digitalis Leaf (Digitalis purpureae folium) 07/2013:0117Dried leaf of Digitalis purpurea L.minimum 0.3 per cent of cardenolic glycosides, expressed as digitoxin (Mr 765) (dried drug).1. Study about the efficacy of digitalis leaf on dogs for mitral valve insufficiency disease (Biller, 1998)(136)
Dioscorea Oppositifolia Rhizome (Dioscoreae oppositifoliae rhizoma) 07/2016:2473Dried, whole or fragmented rhizome of Dioscorea oppositifolia L. (syn. Dioscorea opposita Thunb.)1. Study about the effectsof dioscore modified pill on patients that suffer from VCIND (vascular cognitive impairment no dementia) (Liu, 2014)(138) 2. Clinical trial about how safe is Dioscoreae rhizoma pharmacopunture (according to the extraction method) (Ko, 2013)(137)
Dittany of Crete herb (Origani dictamni herba)Indication 1) Traditional herbal medicinal product used for therelief of cough associated with cold.
Indication 2)
Traditional herbal medicinal product used for the
relief of mild gastrointestinal disorders.
Indication 3)
Traditional herbal medicinal product used for the
relief of minor skin inflammations and bruises.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use
Dog Rose (Rosae pseudo-fructus) 01/2008:1510Rose hips made up by the receptacle and the remains of the dried sepals of Rosa canina L., R. pendulina L. and other Rosa species, with the achenes removed.minimum 0.3 per cent of ascorbic acid (C H O ; Mr 176.1) (dried drug).Adjuvant for the alleviation of pain and joint stiffness associated with osteoarthritis [14-17]. As a supplement in the treatment of colds and chills [2, 18, 19]. Efficacy in this indication is plausible in the basis of human experience and long-standing use.
Dried Bilberry fruit (Myrtilli fructus siccus)
Drynaria Rhizome (Drynariae rhizoma) 07/2012:2563Dried rhizome of Drynaria fortunei (Kunze) J. Sm. The ramenta may be removed.minimum 0.5 per cent of naringin (C27H32O14 ; Mr 580.5) (dried drug).
1. Study about the effectiveness that have Drynaria herb on inflammation and bone activity (Yin, 2015)(139)
Dwarf pine oil (Pini pumilionis aetheroleum) 01/2008:2377Essential oil obtained by steam distillation of the fresh leaves and twigs of Pinus mugo Turra. A suitable antioxidant may be added.
Eclipta herb (Ecliptae herba) 01/2014:2564Dried, whole or fragmented, flowering aerial parts of Eclipta prostrata L.minimum 0.04 per cent of wedelolactone (C16H10O7 ; Mr 314.3) (dried drug).1. Study about Eclipta herb and properties (Sidra, 2013)(140)
Elder Flower (Sambuci flos) 01/2013:1217Dried flower of Sambucus nigra L.minimum 0.80 per cent of flavonoids, expressed as
isoquercitroside (C21H20O12 ; Mr 464.4) (dried drug).
Herbal medicinal product traditionally used for
the relief of early symptoms of common cold.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
NoneAs a diaphoretic for treatment of fever and chills, and as an expectorant for treatment of mild inflammation of the upper respiratory tract. Also for symptomatic treatment of the common cold. Treatment of conjunctivitis, constipation, diabetes, diarrhoea, dry skin, headaches and rheumatismAs a diaphoretic in the treatment of common cold, fever and chills [Bradley 1992, Hiermann 1994, Willuhn 2002] Efficacy is plausible for this indication on the basis of human experience and long-standing use.
Eleutherococcus (Eleutherococci radix) 01/2008:1419Dried, whole or cut underground organs of Eleutherococcus senticosus (Rupr. et Maxim.) Maxim.minimum 0.08 per cent for the sum of eleutheroside B (Mr 372.4) and eleutheroside E (Mr 742.7).Traditional herbal medicinal product for symptoms
of asthenia such as fatigue and weakness.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
As a prophylactic and restorative tonic for enhancement of mental and physical capacities in cases of weakness, exhaustion and tiredness, and during convalescenceTreatment of rheumatoid arthritis, insomnia and dream-disturbed sleep. As a carminative in the treatment of acute and chronic gastritis, as a diuretic, to treat impotence and to regulate blood pressureDecrased mental and physical capacities such as weakness, exhaustion, tiredness and loss of concentration, as well as during convalescence [2, 3, 5-21]1. Study of Eleutherococcus plant (and two more) and his ability to have the property of cardio-protect and antiarrhytmic effect (Maslov, --)(141)
Ephedra Herb (Ephedrae herba) 07/2016:2451Dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C.A.Mey or Ephedra equisetina Bunge.minimum 1.0 per cent of ephedrine (C10H15NO; Mr 165.2) (dried drug).Herba Ephedrae preparations are used in the treatment of nasal congestion due to hay fever, allergic rhinitis, acute coryza, common cold, and sinusitis. The drug is further used as a bronchodilator in the treatment of bronchial asthmaHerba Ephedrae has been used for the treatment of urticaria, enuresis, narcolepsy, myasthenia gravis, and chronic postural hypotension. Other medical uses claimed for Herba Ephedrae preparations include its use as an analgesic, an antiviral agent, an antitussive and expectorant, an antibacterial, and an immune stimulant1. Study about herbs on nephrotoxicity and its mechanisms to intoduce it (Allard, 2013)(135)
Equisetum Stem (Equiseti Herba) 04/2012:1825Whose or cut, dried sterile aerial parts of Equisetum arvense L.minimum 0.3 per cent of total flavonoids, expressed as isoquercitroside (C21H20O12 ; Mr 464.4) (dried drug).Traditional herbal medicinal product to increase
the amount of urine to achieve flushing of the
urinary tract as an adjuvant in minor urinary
complaints.
The product is a traditional herbal medicinal
product for use in specified indication exclusively based upon long-standing use.
Eucalyptus Leaf (Eucalypti folium) 07/2014:1320Whole or cut, dried leaves of older branches of Eucalyptus
globulus Labill.
Essential oil content:
– for the whole drug, minimum 20 mL/kg (anhydrous drug);
– for the cut drug, minimum 15 mL/kg (anhydrous drug).
None.As an expectorant for symptomatic treatment of mild inflammation of the respiratory tract and bronchitis. Also for symptomatic treatment of asthma, fever and inflammation of the throat. Treatment of cystitis, diabetes, gastritis, kidney disease (unspecified), laryngitis, leukorrhoea, malaria, pimples, ringworm, wounds, ulcers of the skin, urethritis and vaginitis1. Article taking about the different exotic species of eucalyptus (Paine, 2011)(144) 2. Potential inluence of plant chemicals on infectivity of Batrachochytrium dendrobatidis (Davidson, 2012)(142) 3. Study of four plants and his effect on their repellent activity (mainly Mansonia population, western Ethopia) (Hadis, 2003)(143)
Eucalyptus oil (Eucalypti aetheroleum) 07/2010:0390Essential oil obtained by steam distillation and rectification from the fresh leaves or the fresh terminal branchlets of various species of Eucalyptus rich in 1,8-cineole.The species mainly used are Eucalyptus globulus Labill., Eucalyptus polybractea R.T.Baker and Eucalyptus smithii R.T.Baker.Indication 1)
Traditional herbal medicinal product used for relief
of cough associated with cold.
Indication 2)
Traditional herbal medicinal product for the
symptomatic relief of localised muscle pain.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
NoneSymptomatic treatment of catarrh and coughs. As a component of certain dental root canal sealers; topically as a rubefacient for treatment of rheumatic complaints. Treatment of cystitis, diabetes, gastritis, kidney disease (unspecified), neuralgia, laryngitis, leukorrhoea, malaria, pimples, ringworm, sinusitis, wounds, ulcers of the skin, urethritis and vaginitis
Eucommia Bark (Eucommiae cortex) 01/2014:2412Whole or fragmented, scraped, dried bark of the stem of Eucommia ulmoides Oliv.minimum 0.10 per cent of pinoresinol diglucoside (C32H42O16 ; Mr 683) (dried drug).1. A full Clinical trial about Eucommia bark (Deyama, 2001)(145)
Evening Primrose Oil (Oenotherae biennis oleum)OMS: fixed oil obtained from the seeds of Oenothera biennis L. (Onagraceae)Traditional herbal medicinal product for the
symptomatic relief of itching in acute and chronic
dry skin conditions.
Internally for symptomatic treatment of atopic eczema, diabetic neuropathy , and mastalgia . Clinical evidence for its use in the treatment of rheumatoid arthritis is conflicting, as are the results of trials in women with premenstrual syndrome. Further well-designed clinical trials are needed to clarify these data. The results from clinical trials do not support the use of Oleum Oenotherae Biennis for the treatment of climacteric symptoms or psoriasisTopical use for the treatment of minor bruises and wounds. Taken internally for the treatment of asthma, coughs, gastrointestinal disorders, pain and whooping cough
Eyebright (Euphrasiae herba)
Fennel, Bitter (Foeniculi amari fructus) 04/2013:0824Dry cremocarps and mericarps of Foeniculum vulgare Mill. ssp. vulgare var. vulgare.– essential oil : minimum 40 mL/kg (anhydrous drug) ; – anethole : minimum 60.0 per cent in the essential oil ; – fenchone: minimum 15.0 per cent in the essential oil.a) Traditional herbal medicinal product for
symptomatic treatment of mild, spasmodic
gastro-intestinal complaints including bloating
and flatulence.
b) Traditional herbal medicinal product for
symptomatic treatment of minor spasm
associated with menstrual periods.
c) Traditional herbal medicinal product used as
an expectorant in cough associated with cold.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
Symptomatic treatment of dyspepsia, bloating and fl atulence.
As an expectorant for mild infl ammation of the upper respiratory tract. Treatment of pain in scrotal hernia, and dysmenorrhoea
Treatment of blepharitis, bronchitis, constipation, conjunctivitis, diabetes,
diarrhoea, dyspnoea, fever, gastritis, headache, pain, poor appetite and
respiratory and urinary tract infections. As an aphrodisiac, anthelminthic,
emmenagogue, galactagogue and vermicide
1. Study about Fennel oil (and caraway) on pigs (Schöne, 2006)(146)
Fennel, sweet (Foeniculi dulcis fructus) 04/2011:0825Dry cremocarps and mericarps of Foeniculum vulgare Mill.
subsp. vulgare var. dulce (Mill.) Batt. & Trab.
– essential oil: minimum 20 mL/kg (anhydrous drug) ; – anethole: minimum 80.0 per cent in the essential oil.a) Traditional herbal medicinal product for
symptomatic treatment of mild, spasmodic
gastro-intestinal complaints including
bloating, and flatulence.
b) Traditional herbal medicinal product for
symptomatic treatment of minor spasm
associated with menstrual periods.
c) Traditional herbal medicinal product used as
an expectorant in cough associated with cold.
The product is a traditional herbal medicinal
product for use in specified indi
1. Study about Fennel oil (and caraway) on pigs (Schöne, 2006)(146)
Fenugreek (Trigonellae foenugraeci secuen) 01/2008:1323Dried, ripe seeds of Trigonella foenum-graecum L.Indication 1)
Traditional herbal medicinal product used for
temporary loss of appetite.
Indication 2)
Traditional herbal medicinal product for the
symptomatic treatment of minor inflammations of
the skin.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
As an adjunct for the management of hypercholesterolaemia, and hyperglycaemia
in cases of diabetes mellitus. Prevention and treatment
of mountain sickness. Internally for loss of appetite, and externally as a poultice for local inflammations . Treatment of pain, and weakness and oedema of the
legs
As an aphrodisiac, carminative, diuretic, emmenagogue, emollient, galactagogue
and tonic. Treatment of abdominal colic, bronchitis, diarrhoea,
eczema, gout, indigestion, dropsy, fever, impotence, chronic cough,
liver disorders, wounds and the common cold
1. Study on hematology and performace about the wastage and energy of vagetebles on ostrich chicks (Tasirnafas, 2015)(148) 2. The use of a medicine is still safe enough? (Medagama, 2014) (147)
Feverfew (Tanaceti parthenii herba) 01/2008:1516Dried, whole or fragmented aerial parts of Tanacetum parthenium (L.) Schultz Bip.minimum 0.20 per cent of parthenolide (C15H20O3 ; Mr 248.3) (dried drug).
Traditional herbal medicinal product for the
prophylaxis of migraine headaches after serious
conditions have been excluded by a medical
doctor.
The product is a traditional herbal medicinal
product for use in specified indication exclusively based upon long-standing use.
Prevention of migraine. Although Herba Tanaceti Parthenii has been used for treatment of rheumatoid arthritis, a clinical study failed to prove any beneficial effectsTreatment of anaemia, arthritis, asthma, common cold, constipation, diarrhoea, dysmenorrhoea, dyspepsia, oedema, fever, indigestion, insect bites, rheumatism, sciatica, tinnitus, toothache and vertigoProphylaxis of migraine [Berry 1984, Johnson 1985, Murphy 1988, Heptinstall 1988, Groenewegen 1992, Palevitsch 1997, Ernst 2000, Pfaffenrath 2002, Diener 2005]1. Feverfew for improving the canine natural osteoarthritis model (Moreau, 2014)(150) 2. Feverefew and its influence on coagulation and platelet function (McEwen, 2015)(149) 3. Feverfew and his effect for anti-inflammatory (Sur, 2009)(151)
Fleeceflower Root (Polygoni multiflori radix) 01/2014:2433Whole or fragmented dried tuberous root of Fallopia multiflora (Thunb.) Haraldson (syn. Polygonum multiflorum Thunb.).minimum 1.0 per cent of 2,3,5,4′-tetrahydroxystil- bene-2-O-β-D-glucoside (C20H22O9 ; Mr 406.4) (dried drug).1. Manual of proper use of fleeceflower root (Lee, 2015)(152) 2. Clinical trial about a treatment of the localized neurodermatitis caused by plu-blossom needle tapping (Weiying, 2006)(153) 3. Fleeceflower as a plant that take part of a combined traditional chinese medicine for treating tinnitus (Yang, 1989) (154)
Fourstamen Stepahnia Root (Stephaniae tetrandrae radix) 01/2013:2478Scraped, cut and dried root of Stephania tetrandra S.Moore.minimum 1.6 per cent of the sum of tetrandrine and fangchinoline, expressed as tetrandrine (C38H42N2O6 ; Mr 623) (dried drug).1. Tetrandrine for cancer chemotheraphy (Liu, 2016)(156) 2. Effect of Fourstamen sthepanie root on neutrophil function in patients with rheumatoid arthritis (Sekiya, 2004) (157)
Frangula Bark (Frangulae Cortex) 04/2011:0025Dried, whole or fragmented bark of the stems and branches of Rhamnus frangula L. (Frangula alnus Miller).minimum 7.0 per cent of glucofrangulins, expressed as glucofrangulin A (C27H30O14 ; Mr 578.5) (dried drug).Herbal medicinal product for short-term use in cases of occasional constipation.Short-term treatment of occasional constipation . As a single dose, for total intestinal evacuation before X-rays and other diagnostic examinations when electrolyte solutions alone are insufficient for adequate evacuation or the use of electrolyte solutions is not possibleAs a cathartic. Internally for treatment of diabetes and externally for skin irritationsFor short term treatment of occasional constipation [9-10]1. Clinical trial about using laxative use in postcolostomy surgery patients (Stott, 2012)(158)
Frangula Bark dry extract, Standardised (Frangulae corticis extractum siccum normatum) 07/2015:1214Standardised dry extract obtained from Frangula bark (0025).15.0 per cent to 30.0 per cent of glucofrangulins, expressed as glucofrangulin A (C27H30O14 ; Mr 578.5) (dried extract). The measured content does not deviate from that stated on the label by more than ± 10 per cent.
Fraxinus Rhynchophylla Bark (Fraxini rhynchophyllae cortex) 01/2015:2452Whole or fragmented, dried branch or trunk bark of Fraxinus rhynchophylla Hance.minimum 1.0 per cent for the sum of esculin (C15H16O9 ; Mr 340.3) and esculetin (C9H6O4 ; Mr 178.1) (dried drug).
Fresh Bilberry fruit (Myrtilli fructus recens)Indication 1)
Traditional herbal medicinal product to relieve
symptoms of discomfort and heaviness of legs
related to minor venous circulatory disturbances.
Indication 2)
Traditional herbal medicinal product to relieve
symptoms of cutaneous capillary fragility.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Fresh bilberry fruit dry extract, Refined and standardised (Myrtilli fructus recentis extractum siccum raffinatum et normatum) 01/2016:2394Refined and standardised dry extract produced from Fresh
bilberry fruit (1602).
32.4 per cent to 39.6 per cent of anthocyanins, expressed as cyanidin 3-O-glucoside chloride [chrysanthemin (C21H21ClO11 ; Mr 484.8)] (dried extract).
Fumitory (Fumariae herba) 01/2013:1869Whole or fragmented, dried aerial parts of Fumaria officinalis L. harvested in full bloomminimum 0.40 per cent of total alkaloids, expressed as protopine (C20H19NO5 ; Mr 353.4) (dried drug).Traditional herbal medicinal product used to
increase bile flow for the relief of symptoms of
indigestion (such as sensation of fullness,
flatulence and slow digestion).
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Digestive complaints (e.g. Stomach ache, nausea, vomiting, feeling of fullness, flatulence) due to hepatobiliary disturbance [16-29].1. Fumitory as a plant and taking part in a treatment involved in irratable bowel syndrome (Brinkhaus, 2005)(161) 2. Discussion about Fumitory and his effect as an antitumor medicine (Gaziano, 2016)(160) 3. Fumitory as a treatment of cholecystopathies (Zacharewicz, 1979)(159)
Garlic (Allii sativi bulbus)· · ·· · ·As an adjuvant to dietetic management in the treatment of hyperlipidaemia, and in the prevention of atherosclerotic (age-dependent) vascular changes . The drug may be useful in the treatment of mild hypertensionThe treatment of respiratory and urinary tract infections, ringworm and rheumatic conditions. The herb has been used as a carminative in the treatment of dyspepsia. As an aphrodisiac, antipyretic, diuretic, emmenagogue, expectorant, and sedative, to treat asthma and bronchitis, and to promote hair growth1. Clinical trial garlic for hypertension (Xiong, 2015)(162) 2. Study of garlic and its advantadges on slow down blood pressure, regulating serum cholesterol and so on (Ried, 2016)(163) 3. Study and proof that aged garlic extract can modify humanimmunity (Percival, 2016) (164)
Garlic Powder (Allii sativi bulbi pulvis) 01/2008:1216Bulbs of Allium sativum L., cut, freeze-dried or dried at a temperature not exceeding 65 °C and powdered.minimum 0.45 per cent of allicin (C6H10OS2 ; Mr 162.3) (dried drug).1. Garlic and its effect on serum lipid profiles (Zeng, 2012)(165) 2. Meta-analysis of garlic related to blood pressure (Wang, 2015)(166) 3. Garlic and its effect on human urinary cytokine excretion (Alma, 2014)(168) 4. Garlic and its effect on serum lipids. Blood pressure and arterial stiffness in normo-lipidaemic volunteers (Turner, 2004)(167)
Gentian Root (Gentianae radix) 07/2017:0392Dried, fragmented underground organs of Gentiana lutea L.Traditional herbal medicinal product used in mild
dyspeptic/gastrointestinal disorders, and/or in
temporary loss of appetite.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
NoneSymptomatic treatment of liver disorders, cholecystitis and lack of appetite. Treatment of convulsions, eczema, fungal infections, hearing impairment,
infl ammation, leukorrhoea, otitis media, urinary tract infections, herpes
zoster and pruritus vulvae
As a bitter in loss of appetite e.g. After illness; dyspeptic complaints [Gnetiana BHP 1983; Wegener 1998; Meier 2007; Schilcher 2010]1. Gentian root for promoting blood circulation and removing bloos stasis on treatmenrs related to movement (Xu, 2009)(169) 2. Gentian root and indigestion (McMullen, 2015)(170)
Gentian tincture (Gentianae tinctura) 01/2008:1870Tincture produced from Gentian root (0392).
Ginger (Zingiberis rhizoma) 01/2011:1522Dried, whole or cut rhizome of Zingiber officinale Roscoe, with the cork removed, either completely or from the wide, flat surfaces only.minimum 15 mL/kg of essential oil (anhydrous drug).Indication 1)
Traditional herbal medicinal product for the
symptomatic relief of motion sickness.
Indication 2)
Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic
gastrointestinal complaints including
bloating and flatulence.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Herbal medicinal product for the prevention of
nausea and vomiting in motion sickness.
The prophylaxis of nausea and vomiting associated with motion sickness, postoperative nausea, pernicious vomiting in pregnancy, and seasicknessThe treatment of dyspepsia, flatulence, colic, vomiting, diarrhoea, spasms, and other stomach complaints . Powdered ginger is further employed in the treatment of colds and flu, to stimulate the appetite, as a narcotic antagonist, and as an anti-inflammatory agent in the treatment of migraine headache and rheumatic and muscular disorders. To treat cataracts, toothache, insomnia, baldness, and haemorrhoids, and to increase longevityProphylaxis of the nausea and vomiting of motion sickness [15-19], and as a postoperative antiemetic for minor day-case surgical procedures [20, 21].1. Ginger extract for pain (Lakhan, 2015)(174) 2. Efficacy of ginger on osteoarthritis patients (Bartels, 2015)(173) 3.Ginger as a dietary supplement fo dysmenorrhoea (Pattanittum, 2016)(175) 4. Efficacy of ginger for treatment of digestive reflux disroders (Ling, 2015)(172) 5. Effect and safety of ginger in the treatment of nausea and vomiting with pregnant women (Viljoen, 2014) (171)
Ginkgo Leaf (Ginkgonis folium) 01/2011:1828Whole or fragmented, dried leaf of Gingko biloba L.not less than 0.5 per cent of flavonoids, expressed as flavone glycosides (Mr 757) (dried drug).Traditional herbal medicinal product for the relief
of heaviness of legs and the sensation of cold
hands and feet associated with minor circulatory
disorders, after serious conditions have been
excluded by a medical doctor. The product is a traditional herbal medicinal
product for use in specified indication exclusively
based upon long-standing use
Herbal medicinal product for the improvement of
(age-associated) cognitive impairment and of
quality of life in mild dementia.
Extracts as described above (Dosage forms) have been used for symptomatic treatment of mild to moderate cerebrovascular insufficiency (demential syndromes in primary degenerative dementia, vascular dementia, and mixed forms of both) with the following symptoms: memory deficit, disturbance in concentration, depressive emotional condition, dizziness, tinnitus, and headache. Such extracts are also used to improve pain-free walking distance in people with peripheral arterial occlusive disease such as intermittent claudication, Raynaud disease, acrocyanosis, and post-phlebitis syndrome, and to treat inner ear disorders such as tinnitus and vertigo of vascular and involutive origin. Extracts and doses other than those described in Dosage forms and Posology are used for similar but milder indicationsAs a vermifuge, to induce labour, for the treatment of bronchitis, chronic rhinitis, chilblains, arthritis, and oedemaSymptomatic treatment of: mild to moderate dementia syndromes including primary degenerative dementia, vascular dementia and mixed forms [24-29]; cerebal insufficiency [30-37]. Neurosensory disturbances such as dizziness/vertigo [38, 39] and tinnitus [40, 41]. Enhancement of cognitive performance [42- 52].1. Ginkgo for memory effects on middle-aged people (Kaschel, 2011)(177) 2. Study of ginkgo and possibility of bleeding because its extract (Kellermann, 2011)(176) 3. Gingko for dementia and cognitive impairment (Birks, 2009)(178)
Ginkgo dry extract, Refined and quantified (Ginkgonis extractum siccum raffinatum et quantificatum) 04/2008:1827Refined and quantified dry extract produced from Ginkgo leaf
(1828).
– flavonoids, expressed as flavone glycosides (Mr 756.7): 22.0 per cent to 27.0 per cent (dried extract);
– bilobalide: 2.6 per cent to 3.2 per cent (dried extract);
– ginkgolides A, B and C: 2.8 per cent to 3.4 per cent (dried
extract) ;
– ginkgolic acids: maximum 5 ppm (dried extract).
Ginseng (Ginseng radix) 01/2016:1523Whole or cut dried root, designated white ginseng; treated
with steam and then dried, designated red ginseng, of Panax ginseng C. A. Mey.
minimum 0.40 per cent for the sum of ginsenosides Rg1 (C42H72O14,2H2O; Mr 837) and Rb1 (C54H92O23,3H2O; Mr 1163) (dried drug).
Traditional herbal medicinal product for symptoms
of asthenia such as fatigue and weakness.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use
Radix Ginseng is used as a prophylactic and restorative agent for enhancement of mental and physical capacities, in cases of weakness, exhaustion, tiredness, and loss of concentration, and during convalescenceRadix Ginseng has been used clinically in the treatment of diabetes, but further clinical studies are needed. The drug is also used in the treatment of impotence, prevention of hepatotoxicity, and gastrointestinal disorders such as gastritis and ulcers. Treatment of liver disease, coughs, fever, tuberculosis, rheumatism, vomiting of pregnancy, hypothermia, dyspnoea, and nervous disorders1. Study of ginseng on glycemic control (Shishtar, 2014)(181) 2. Ginseng uses (Wang, 2016)(180) 3. Ginseng for imporving quality life of hepatic dysfucntion in patients with symptomatic chronic heart failure (Wei, 2015)(179) 4. Ginseng for treating erectile dysfunction (Jang, 2008)(182)
Ginseng dry extract (Ginseng extractum siccum) 01/2013:2356Dry extract produced from Ginseng (1523).minimum 4.0 per cent of the sum of ginsenosides Rb1, Rb2, Rc, Rd, Re, Rf, Rg1 and Rg2, expressed as ginsenoside Rb1 (C54H92O23 ; Mr 1109) (dried extract).
Goldenrod (Solidaginis herba) 04/2014:1892Whole or cut, dried, flowering aerial parts of Solidago gigantea Ait. or Solidago canadensis L., their varieties or hybrids and/or mixtures of these.minimum 2.5 per cent of flavonoids, expressed as hyperoside (C21H20O12 ; Mr 464.4) (dried drug).1. Can goldenrod decrease microbial colonization and biofilm developement in indwelling urinary catheter? (Cai, 2014)(185) 2. Goldenrod and its toxicosis (Davis, 2013)(183) 3. Treatmentof tendonitis of flexor and extensor tendons of wrist and hand (da Silva, 2015)(184) 4. Herbal medicines, beneficial or disadvantage on urinary tract infections (Bastigkeit, 2015) (59)
Goldenrod, European (Solidaginis virgaureae herba) 01/2013:1893Whole or fragmented, dried, flowering aerial parts of Solidago virgaurea L.minimum 0.5 per cent and maximum 1.5 per cent of flavonoids, expressed as hyperoside (C21H20O12 ; Mr 464.4) (dried drug).Traditional herbal medicinal product to increase
the amount of urine - as adjuvant in treatment of
minor urinary complaints.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
1. Can goldenrod decrease microbial colonization and biofilm developement in indwelling urinary catheter? (Cai, 2014)(185) 2. Goldenrod and its toxicosis (Davis, 2013)(183) 3. Treatmentof tendonitis of flexor and extensor tendons of wrist and hand (da Silva, 2015)(184) 4. Herbal medicines, beneficial or disadvantage on urinary tract infections (Bastigkeit, 2015) (59)
Goldenseal, Rhizome (Hydrastis rhizoma) 01/2011:1831Whole or cut, dried rhizome and root Hydrastis canadensis L.– hydrastine (C21H21NO6 ; Mr 383.4) : minimum 2.5 per cent
(dried drug);
– berberine (C20H18NO4 ; Mr 336.4) : minimum 3.0 per cent (dried drug).
NoneTreatment of digestive complaints, such as dyspepsia, gastritis, feeling of
distension and flatulence. Treatment of cystitis, dysmenorrhoea, eczema, haemorrhoids, uterine
haemorrhage, infl ammation, kidney diseases, menorrhagia, nasal congestion,
tinnitus and vaginitis. As a cholagogue, diuretic, emmenagogue,
haemostat, laxative and tonic
Digestive disorders such as dyspeptic complaints and gastritis; as an adjuvant in menorrhagia and dysmenorrhoea [Blaschek 2007, Barnes 2007, Mills 2013, Bradley 1992] Efficacy in these indications is plausible on the basis of human experience and long-standing use.1. Goldenseal as a supplemention (and kava kava) on digoxin pharmacokinetics in humans (Gurley, 2007)(188) 2. Goldenseal as asupplement (and not kava kava) inhibits human CYP3A activity in vivo study (Gurlaey, 2008)(187) 3. Goldenseal metabolism and pharmacokinetic diversity of ranunculaceae medicinal compounds (Hao, 2015) (186)
Grapevine leaf (Vitis vinifera folium)Indication 1)
Traditional herbal medicinal product to relieve
symptoms of discomfort and heaviness of legs
related to minor venous circulatory disturbances.
Indication 2)
Traditional herbal medicinal product for
symptomatic relief of itching and burning
associated with haemorrhoids.
Indication 3)
Traditional herbal medicinal product for
symptomatic treatment of cutaneous capillary
fragility.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Herbal medicinal product for treatment of chronic
venous insufficiency, which is characterised by
swollen legs, varicose veins, a feeling of
heaviness, pain, tiredness, itching, tension and
cramps in the calves.
Greater Celandine (Chelidonii herba) 07/2012:1861Dried, whole or cut aerial parts of Chelidonium majus L. collected during flowering.minimum 0.6 per cent of total alkaloids, expressed as chelidonine (C20H19NO5 ; Mr 353.4) (dried drug).1. Thiophosphoric acid (derivated form greater celandine) as an immunostimulant in patients with carcinomas (Nowicky, 1991)(190) 2. Greater celandine hepatotoxicity' study (Teschke, 2013)(189)
Green bean pod (Phaseoli fructus (sine semine))Traditional herbal medicinal product used to
increase the amount of urine to achieve flushing
of the urinary tract as an adjuvant in minor
urinary tract complaints.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Green tea (Camelliae sinensis non fermentatum folium)Traditional herbal medicinal product for relief of fatigue and sensation of weakness. The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
1. Green tea as a supplement for postmenipausal women and with risk for breast cancer (Dostal, 2015)(194) 2. New applications of green tea flower and its biactive acylated oleanane-type triterpene oligoglycosides (Matsuda, 2016)(192) 3. Study of green tea and its refusal to absorb fatt (Janssens, 2015)(193) 4. Study of green (and black) tea and their relation to gynecologic cancers (Butler, 2011)(195) 5. Effect of dietary supplemention (with pills related to green tea) on weight loss, energy homeostasis and so on (Mielgo-Ayuso, 2014) (191)
Guar (Cymopsidis seminis pulvis) 01/2010:1218Guar is obtained by grinding the endosperms of seeds of Cyamopsis tetragonolobus (L.) Taub. It consists mainly of guar galactomannan.1. Dietary interventions for familial hypercholesterolaemia (Malhotra, 2014)(196) 2. Study on a theraphy related to chronic anal fissure (Brillantino, 2014)(200) 3. Treating cholestasis during pregnancy (Gurung, 2013)(197) 4. Reduce cholesterol via dietary fiber (Brown, 1999)(199) 5. Guar and its effect on dose on glycemin control where they were two types of diabetes patients (Clifton, 2014) (198)
Guarana seed (Paulliniae semen)1. Study about a product containg guaraná on psychological well-being anxiety and mood (Silvestrini, 2013)(201) 2. Guara seed for overweight patients following a south american herbal preparation (Andersen, 2001)(203) 3. Guarana as a plant with a very high level of caffeine (Schimpl, 2013)(202)
Hamamelis Bark (Hamamelidis cortex) 01/2016:2532Cut, dried bark from the trunk and branches of Hamamelis virginiana L.minimum 5.0 per cent of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1) (dried drug).a) Traditional herbal medicinal product for relief of minor skin inflammation and dryness of the skin. b) Traditional herbal medicinal product for symptomatic relief of itching and burning associated with haemorrhoids. c) Traditional herbal medicinal product used as a mouthwash and gargles for relief of minor inflammation of mucous membranes of the oral cavity. The product is a traditional herbal medicinal product for use in the specified indications exclusively based upon long-standing use.Topically for minor skin lesions, bruises and sprains local inflammation of the skin and mucous membranes, haemorrhoids and varicose veinsTopically as a haemostat. Treatment of colitis, diarrhoea, dysentery, dysmenorrhoea, eye inflammations, haematuria, kidney pains, neuralgia, nosebleeds and excessive menstruation. Also as a tonicINTERNAL USE: Inflammation of mucous membranes of the oral cavity [Hoffmann-Bohm 1993, Laux 1993, Hiller 2009] Short-term symptomatic treatment of diarrhoea [Hamamelis Bark, Laux 1993, Bradley 2006] EXTERNAL USE: Haemorrhoids [Reynolds 1982, Van Hellemont 1988, Hoffmann-Bohm 1993, Laux 1993, Bradley 2006, Schilcher 2007, Hiller 2009], minor injuries and local inflammations of the skin [Reynolds 1982, Hoffmann-Bohm 1993, Laux 1993, Hörmann 1994, Millikan 2003, Bradley 2006, Bühring 2008, Hiller 2009, Schilcher 2010]. Efficacy in these indications is plausible on the basis of human experience and long-staning use.
Hamamelis leaf and bark or twigs distillate (Hamamelidis folium et cortex aut ramunculus destillatum)a) Traditional herbal medicinal product for relief of minor skin inflammation and dryness of the skin. b) Traditional herbal medicinal product to be used for the temporary relief of eye discomfort due to dryness of the eye or to exposure to wind or sun. The product is a traditional herbal medicinal product for use in the specified indications exclusively based upon long-standing use.
Hamamelis Leaf (Hamamelidis folium) 01/2011:0909Whole or cut, dried leaf of Hamamelis virginiana L.Content: minimum 3 per cent of tannins, expressed as
pyrogallol (C6H6O3 ; Mr 126.1) (dried drug).
a) Traditional herbal medicinal product for relief
of minor skin inflammation and dryness of the
skin.
b) Traditional herbal medicinal product for
symptomatic relief of itching and burning
associated with haemorrhoids.
c) Traditional herbal medicinal product used as a
mouthwash and gargles for relief of minor
inflammation of mucous membranes of the
oral cavity.
The product is a traditional herbal medicinal
product for use in specified indication exclusively
based upon long-standing use.
INTERNAL USE: Symptomatic treatment of complaints related to varicose veins, such as paintful and heavy legs, and of haemorrhoids [Bernard 1977, van Hellemont 1988, Hoffmann-Bohm 1993, Laux 1993, Hörmann 1994, MacKay 2001, Egerer 2005, Hiller 2009, Schilcher 2010]. EXTERNAL USE: Bruises, sparins and minor injuries of the skin [Hoffmann-Bohm 1993, Laux 1993, Bradley 2006, Bühring 2008, Hiller 2009]. Local inflammations of the skin and mucosa [Bernard 1977, Hoffmann-Bohm 1993, Laux 1993, Millikan 2003, bradley 2006, Bühring 2008, Hiller 2009, Schilder 2010] haemorrhoids [Hoffmann-Bohm 1993, Laux 1993, hamamelis Leaf (BHP) 1983, Bardley 2006, Hiller 2009, Schilcher 2010]. Relief of the symptoms of neurodermitis atopica [Wokalek 1993, bradley 2006] and feeling of heavy legs [Hoffmann-Bohm 1993]. Efficacy in these indications is plausible on the basis of human experience and long-standing use.1. Hamamelis use for cooling for relieving pain from perineal trauma during childbirth (East, 2012)(206) 2. Hamamelis use for antiiflammatory (Beikert,2013) (207)
Hawthorn Berries (Crataegi fructus) 04/2013:1220Dried false fruits of Crataegus monogyna Jacq. (Lindm.) or C. laevigata (Poir.) DC. (syn. C. oxyacantha L.) or their hybrids or a mixture of these false fruits.minimum 0.06 per cent of procyanidins, expressed as cyanidin chloride (C15H11ClO6 ; Mr 322.7) (dried drug).1. Hawthorn berries treatment for older patients that suffer fromt orthostatic hypotension (Kroll, 2005)(210) 2. Traditional chinese medication for fatty liver disease and so on (Shi, 2012)(208) 3. Study of Hawthorn berries beneficial treatment for blood presure (Erfurt, 2014)(211) 4. Hawthorn berries study about increasing blood pressure and cognitive functioning in elderly (Werner, 2009)(209)
Hawthorn Leaf and Flower (Crataegi folium cum flore) 01/2010:1432Whole or cut, dried flower-bearing branches of Crataegus monogyna Jacq. (Lindm.), C. laevigata (Poir.) DC.
(syn. C. oxyacanthoides Thuill.; C. oxyacantha auct.)
minimum 1.5 per cent of total flavonoids, expressed as hyperoside (C21H20O12 ; Mr 464.4) (dried drug).Traditional useTreatment of chronic congestive heart failure stage II, as defined by the New York Heart AssociationSupport of cardiac and circulatory functions. As an antispasmodic agent in the treatment of asthma, diarrhoea, gall bladder disease and uterine contractions, and as a sedative for the treatment of insomnia.1. Extract of hawthorn leaf and flower for cardiovascular disorders (Koch, 2011)(213) 2. Extract for heart failure treatment (Pittler, 2008)(212) 3. Hawthorn leaf and flower for neutrophil elstase and its hypolipidemic effect (Dalli, 2011) (214)
Hawthorn leaf & flower dry extract (Crataegi foliicum florae extractum siccum) 01/2010:1865Dry extract produced from Hawthorn leaf and flower (1432).– for aqueous extracts: minimum 2.5 per cent of total
flavonoids, expressed as hyperoside (C21H20O12 ; Mr 464.4) (dried extract); –for hydroalcoholic extracts: minimum 6.0 per cent of total flavonoids, expressed as hyperoside (C21H20O12 ; Mr 464.4) (dried extract).
Hawthorn leaf &flower liquid extract quantified (Crataegi foliicum florae extractum fluidum quantificatum) 01/2008:1864Quantified liquid extract produced from Hawthorn leaf with
flower (1432).
0.8 per cent to 3.0 per cent of flavonoids, expressed
as hyperoside (C21H20O12 ; Mr 464.4).
Hedge mustard (Sisymbrii officinalis herba)Traditional herbal medicinal product for the relief
the symptoms of throat irritation such as
hoarseness and dry cough.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Hop Strobile (Lupuli flos) 01/2011:1222Dried, generally whole, female inflorescence of Humulus lupulus L.Traditional herbal medicinal product for relief of
mild symptoms of mental stress and to aid sleep.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based on long standing use.
None.As a sedative for the treatment of nervous tension and insomnia. Treatment
of dyspepsia and lack of appetite. Treatment of abdominal cramps, anaemia, bacterial infections, dermatitis,
diarrhoea, dysmenorrhoea, leukorrhoea, migraine and oedema. As an
analgesic, anthelminthic, antipyretic, aphrodisiac, carminative, depurative,
digestant, diuretic, diaphoretic and tonic
Tenseness, restlessness and sleep disorders [4, 17-20]
Horse-chestnut (Hippocastani semen) 01/2017:1830Whole of fragmented, dried, ripe seed of Aesculus hippocastanum L.minimum 1.5 per cent of triterpene glycosides, expressed as protoaescigenin (C30H50O6 ; Mr 506.7) (dried drug).A) Traditional herbal medicinal product to relive symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances. B) Traditional herbal medicinal product for relief of signs of bruises, such as local oedema and haematoma. The product is a traditional herbal medicinal product for use in the specified indications exclusively based upon long-standing use.Herbal medicinal product for treatment of chronic venous insufficiency, which is characterised by swollen legs, varicose veins, a feeling of heaviness, pain, tiredness, itching, tension and cramps in the calves.Internally, for treatment of symptoms of chronic venous insufficiency, including pain, feeling of heaviness in the legs, nocturnal calf-muscle spasms, itching and oedema. Externally, for the symptomatic treatment of chronic venous insufficiency, sprains and bruisesTreatment of coronary heart disease. Treatment of bacillary dysentery and fevers. Also as a haemostat for excessive menstrual or other gynaecological bleeding, and as a tonic1. Use for post-thrombotic syndrome treatment (Morlig, 2015)(217) 2. Horse-chestnut study for use effectively the chronic venous insufficiency treatment (Pittler, 2012)(216) 3. Horse-chestnut for venous insufficiency treatment (seed extract) (Suter, --)(215) 4. Control of the horse-chestnut and its treatment of chronic venous insufficiency (Dickson, 2004) (218)
Horse-chestnut bark (Hippocastani cortex)Indication 1)
Traditional herbal medicinal product for relief of
symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances.
Indication 2)
Traditional herbal medicinal product for
symptomatic relief of itching and burning
associated with haemorrhoids, after serious
conditions have been excluded by a medical
doctor.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Horse-chestnut dry extract, Standardised (Hippocastani seminis extractum siccum normatum) 01/2017:1829Standardised dry extract produced from Horse-chestnut
(1830).
6.5 per cent to 10.0 per cent of total triterpene glycosides, expressed as protoaescigenin (C30H50O6 ; Mr 506.7) (dried extract).
Horse-Chestnut Seed (Hippocastani semen)a) Traditional herbal medicinal product to relieve
symptoms of discomfort and heaviness of legs
related to minor venous circulatory disturbances.
b) Traditional herbal medicinal product for relief
of signs of bruises, such as local oedema and
haematoma.
The product is a traditional herbal medicinal
product for use in the specified indications
exclusively based upon long-standing use.
Herbal medicinal product for treatment of chronic
venous insufficiency, which is characterised by
swollen legs, varicose veins, a feeling of
heaviness, pain, tiredness, itching, tension and
cramps in the calves.
1. Horse-chestnut for venous insufficiency treatment (seed extract) (Suter, --)(215)
Iceland Moss (Lichen islandicus) 07/2010:1439Whole or cut, dried thallus of Cetraria islandica (L.) Acharius s.l.Indication 1)
Traditional herbal medicinal product used as a
demulcent for the symptomatic treatment of oral
or pharyngeal irritation and associated dry cough.
Indication 2)
Traditional herbal medicinal product used in
temporary loss of appetite.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Used orally as a demulcent to treat inflammation and dryness of the pharyngeal
mucosa. Used orally for treatment of loss of appetite and nausea
Used to treat asthma, cramps, bronchitis, cough, diabetes, exhaustion,
gastric disturbances, immune depletion, migraine, nausea in pregnancy
and wounds. Also used as an emergency food source, an emollient and a
galactagogue
Indian Frankincense (Olibanum indicum) 01/2013:2310Air-dried gum-resin exudate, obtained by incision in the stem
or branches of Boswellia serrata Roxb. ex Colebr.
– 11-keto-β-boswellic acid (C30H46O4 ; Mr 470.7) : minimum 1.0 per cent (dried drug);
– acetyl-11-keto-β-boswellic acid (C32H48O5 ; Mr 512.7) : minimum 1.0 per cent (dried drug).
Indigo Plant Leaf (Pericariae tinctoriae folium) 01/2016:2727Whole or fragmented, dried leaf of Persicaria tinctoria (Aiton) H.Gross (syn. Polygonum tinctorium Aiton) collected in summer and autumn.minimum 0.55 per cent of indigo (C16H10N2O2 ; Mr 262.3) (dried drug).
Ipecacuanha liquid extract, standardised (Ipecacuanhae extractum fluidum normatum) 01/2008:1875Standardised liquid extract produced from Ipecacuanha root (0094).1.80 per cent to 2.20 per cent of total alkaloids, calculated as emetine (C29H40N2O4 ; Mr 480.7).
Ipecacuanha Root (Ipecacuanhae radix) 04/2016:0094Fragmented and dried underground organs of Carapichea ipecacuanha (Brot.) L. Andersson (syn. Cephaëlis ipecacuanha (Brot.) A. Rich.; Cephaëlis acuminata H. Karst.) from Mato Grosso or Costa Rica. The principal alkaloids are emetine and cephaeline.minimum 2.0 per cent of total alkaloids, expressed as emetine (C29H40N2O4 ; Mr 480.6) (dried drug).Treatment of parasites, the common cold and diarrhoea. Also to
stimulate uterine contractions and induce abortion
Ipecacuanha, Prepared (Ipecacuanhae pulvis normatus) 04/2016:0093Ipecacuanha root (0094) powdered (180) (2.9.12) and adjusted, if necessary, by the addition of powdered lactose or ipecacuanha root powder with a lower alkaloidal content.1.9 per cent to 2.1 per cent of total alkaloids, expressed as emetine (C29H40N2O4 ; Mr 480.6) (dried drug).
Ipecacuanha tincture, Standardised (ipecacuanhae tinctura normata) 01/2008:1530Tincture produced from Ipecacuanha root (0094). 0.18 per cent m/m to 0.22 per cent m/m of total alkaloids, calculated as emetine (C29H40N2O4 ; Mr 480.7).
Ironwort (Sideritis herba)1. Study of the impact of a jelly (containg herbal plants) on human faecal mircrobiota (Mitsou, 2009)(221) 2. Study of the antidioxidant effect of a functional food on healthy humans (Skouroliakou, 2009)(220) 3. Ironwort general information and uses (Todorova, 2014)(219)
Isatis root /Isatidis radix) 01/2012:2566Dried root of Isatis tinctoria L. (I. indigotica Fortune) collected in autumn.minimum 1.0 per cent of arginine (C6H14N4O2 ; Mr 174.2) (dried drug).1. Isatis root eyedrops for acute bacterial conjuctivitis (Qi, 2007)(225) 2. How to identificate, classificate and computate Isatis root (Zhang, 2016)(223) 3. Isatis root is administrated by caccination in chickens, does this plant have immonupotentiating effects? (Qiu, 2007)(224) 4. Different effects that Isatis root does once is induced by radiation on mucositis (You, 2009)(222)
Ispaghula Husk (Plantaginis ovatae seminis tegumentum) 01/2008:1334Episperm and collapsed adjacent layers removed from the
seeds of Plantago ovata Forssk. (P. ispaghula Roxb.).
Indication 1)
Herbal medicinal product for the treatment of
habitual constipation.
Indication 2)
Product in conditions in which easy defaecation with soft stool is desirable, e.g.
in cases of painful defaecation after rectal or anal
surgery, anal fissures and haemorrhoids.
Indication 3)
Product in patients to whom anincreased daily fibre intake may be advisable e.g.
as an adjuvant in constipation predominant
irritable bowel syndrome, as an adjuvant to diet in
hypercholesterolemia (see section 4.4 Special
warnings and precautions for use and section 5.1
Pharmacodynamic properties).
Treatment of occasional constipation [5-12]. Conditions in which easy defecation with soft stools is desirable, e.g. in cases of anal fissures of haemorrhoids [13], after rectal or anal surgery, and during pregancy. Conditions which need an increased daily intake of fibre, e.g. irritable bowel syndrome [14-16]. Adjuvant symptomatic therapy in cases of diarrhoea from various causes [17-23]. As an adjunct to a low fat diet in the treatment of mild to moderate hypercholesterolaaemia [24-54].1. Study of the clinical response of Ispaghula husk for diarrhea-dominant irritable bowel syndrome ' treatment (Abbas, 2014)(226)
Ispaghula Seed (Plantaginis ovatae semen)Indication 1)
Herbal medicinal product for the treatment of
habitual constipation.
Indication 2)
Herbal medicinal product in conditions in which
easy defecation with soft stool is desirable, e.g. in
cases of painful defecation after rectal or anal surgery, anal fissures and haemorrhoids.
Ivy Leaf (Hederae folium) 04/2014:2148Whole or cut, dried leaves of Hedera helix L., collected in spring and summer.minimum 3.0 per cent of hederacoside C (C59H96O26 ; Mr 1221) (dried drug).Herbal medicinal product used as an expectorant in case of productive coughCoughs, particularly when associated with hypersecretion of viscous mucus, as adjuvant treatment of inflammatory bronchial diseases [4-11]1. Ivy leaf treatment for colds accompanied by coughing, tolerability and safety (Stauss-grabo, 2011)(228) 2. Study of tolerance safety and efficacy of ivy leaf application in inflammatory bronchial diseases under clinical practise condition (Fazio, 2009)(230) 3. Study of children administered with dry extract ivy leaf with bronchial asthma (Hofmann, 2003)(229) 4. Study about ivy leaf theraphy for acute bronchitis (Cwientzek, 2011)(231) 5. Ivy leaf for patients with respiratory diseases (Zeil, 2014) (227)
Java Tea (Orthosiphonis folium) 01/2016:1229Whole or fragmented, dried leaf and top of stem of Orthosiphon aristatus (Blume) Miq. var. aristatus (syn. Orthosiphon stamineus Benth.).minimum 0.3 per cent of rosmarinic acid (C18H16O8 ; Mr 360.3) (dried drug).
Traditional herbal medicinal product used to
increase the amount of urine to achieve flushing
of the urinary tract as an adjuvant in minor urinary tract complaints.
The product is a traditional herbal medicinal
product for use in specified indication exclusively
based on long-standing use.
Irrigation of the urinary tract, especially in cases of inflammation and renal gravel, and as an adjuvant in the treatment of bacterial infections of the urinary tract [Proksch 1992, Premgamone 2001, Fintelmann 2002, Jänicke 2003, Bradley 2006, Merfort 2007, Premgamone 2007, Kieley 2008, Schilcher 2010]. Efficacy in these indications is plausible on the basis of human experience and long-standing use.1. Study of Java tea and three more plants for diuretic effect (Doan, 1992)(232) 2. Java tea: uses, toxicology, pharmacology in general (Ameer, 2012)(233)
Juniper (Juniperi galbulus) 07/2013:1532Dried ripe cone berry of Juniperus communis L.minimum 10 mL/kg of essential oil (anhydrous drug)
Juniper Oil (Juniperi aetheroleum) 07/2013:1832Essential oil obtained by steam distillation from the ripe, non-fermented berry cones of Juniperus communis L. A suitable antioxidant may be added.ORAL USE Indication 1) Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary tract complaints. Indication 2) Traditional herbal medicinal product for symptomatic relief of digestive disorders such as dyspepsia and flatulence. CUTANEOUS USE Indication 3) Traditional herbal medicinal product as adjuvant in the relief of minor muscular and articular pain. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.1. Safety assessment of Juniper oil (--, 2001) (234)
Juniper berry (Juniperi pseudo-fructus)Indication 1)
Traditional herbal medicinal product to increase
the amount of urine to achieve flushing of the
urinary tract as an adjuvant in minor urinary tract
complaints.
Indication 2)
Traditional herbal medicinal product for
symptomatic relief of digestive disorders such as
dyspepsia and flatulence.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Kalmegh (Andrographidis paniculatae folium)OMS: dried aerial parts of Andrographis paniculata (Burm. f.) Nees (Acanthaceae)Prophylaxis and symptomatic treatment of upper respiratory infections, such as the common cold and uncomplicated sinusitis , bronchitis and pharyngotonsillitis, lower urinary tract infections and acute diarrhoeaTreatment of bacillary dysentery, bronchitis, carbuncles, colitis, coughs, dyspepsia, fevers, hepatitis, malaria, mouth ulcers, sores, tuberculosis and venomous snake bites. Treatment of colic, otitis media, vaginitis, pelvic inflammatory disease, chickenpox, eczema and burns1. KalmCold™ for patients with uncomplicated upper respiratory tract infection, a clinical trial (Saxena, 2010)(236) 2. Comparation of different herbal drugs on the semen quality of healthy male subjects (Mkrtchyan, 2005)(239) 3. Survey of malaria remedies, including Kalmegh (Nagendrappa, 2013)(238) 4. Kalmegh extract for active ulcerative colitis (Sandborn, 2013)(237)
Katula (Picrorhizae kurroae rhizoma et radix)Used orally to treat anaemia, asthma, diarrhoea, dyspepsia, fever, headaches,
obesity, malaria and stomach ache. Also used as an anti-inflammatory
agent, a cathartic, a cholagogue and an emmenagogue
1. Study of a treatment with oral AKL1 (for chronic obstructive pulmonary disease (Brockwell, 2014)(240)
Kava Kava (Piperis methystici rhizoma)OMS: dried rhizomes of Piper methysticum G. Forst. (Piperaceae) (1-3)Short-term symptomatic treatment of mild states of anxiety or insomnia, due to nervousness, stress or tension.To induce relaxation, reduce weight and treat fungal infections. Treatment of asthma, common cold, cystitis, gonorrhoea, headaches, menstrual irregularities, urinary infections and warts1. Survey about proving if kava extract is effective for treating anxiety (Abadi, 2001)(244) 2. Clinical trial investigating if Vitamin D with mEmantine can treat with alzheimer (Annweiler, 2011)(243) 3. Study of Kava and depression (Sarris, 2009)(242) 4. Effect of kava-kava (extract) on patients with non-psychotic anxiety disorders (Wittle, 2005)(241)
Kelp (Fucus vel Ascophyllum) 01/2008:1456Fragmented dried thallus of Fucus vesiculosus L. or F. Serratus L. or Ascophyllum nodosum Le Jolisminimum 0.03 per cent and maximum 0.2 per cent of total iodine (Ar 126.9) (dried drug).1. Study of kelp's periplastidal compartment (Grosche, 2014)(246) 2. Study of kelp effect on mentrual cycle length and hormonal status in three pre.menopausal women (Skibola, 2004)(71) 3. Study about demonstrating that alterations to bottom-up forcing can cause major disturbances leading to loss of dominant vegetation (Hughes, 2013)(245)
Knotgrass (Polygoni avicularis herba) 07/2013:1885Whole or fragmented, dried flowering aerial parts of
Polygonum aviculare L. s.l.
minimum 0.30 per cent of flavonoids, expressed as
hyperoside (C21H20O12 ; Mr 464.4) (dried drug).
Kudzuvine Root (Puerariae lobatae radix) 01/2012:2434Fragmented, dried root of Pueraria lobata (Willd.) Ohwi.minimum 6.5 per cent of total isoflavonoids, expressed as puerarin (C12H20O9 ; Mr 416.4) (dried drug), of which minimum 45 per cent consists of puerarin.1. Survey of the effect that lixu jieyu recipe has on patients with chronic fatigue syndrome treatment (Zhang, 2009)(247)
Lavender Flower (Lavandulae flos) 04/2011:1534Dried flower of Lavandula angustifolia Mill. (L. officinalis Chaix).minimum 13 mL/kg of essential oil (anhydrous drug).
Traditional herbal medicinal product for relief of
mild symptoms of mental stress and exhaustion
and to aid sleep.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
NoneSymptomatic treatment of restlessness, insomnia, and as a carminative
and antispasmodic for gastrointestinal disorders of nervous origin. Externally in balneotherapy for the treatment of cardiovascular disorders. As a diuretic and an emmenagogue, and for the treatment of burns, diarrhoea,
headaches, sore throats and wounds
1. Lavender flower oil for pain relief (Sheikhan, 2012)(250) 2. Lavender flower oil for episiotomy during recovery (Vakilian, 2011)(249) 3. Research about Lavender flower and its developement (Wang, 2009)(248) 4. Study of Silexan on the serotonin-1A receptor effects and microstructure of the human brain (Baldinger, 2014)(251) 5.Survey of the effect that lixu jieyu recipe has on patients with chronic fatigue syndrome treatment (Zhang, 2009) (247)
Lavender Oil (Lavandulae aetheroleum)Essential oil obtained by steam distillation from the flowering tops of Lavandula angustifolia Mill. (Lavandula officinalis Chaix).Traditional herbal medicinal product for relief of
mild symptoms of mental stress and exhaustion
and to aid sleep.
The product is a traditional herbal medicinal
product for use in the specified indication exclusively based upon long-standing use.
Inhalation therapy for symptomatic treatment of anxiety, restlessness and
to induce relaxation. Externally in balneotherapy for the treatment
of circulation disorders
Symptomatic treatment of insomnia, and as a carminative for the treatment
of gastrointestinal disorders of nervous origin. Orally as a cholagogue, diuretic and emmenagogue; externally for the
treatment of burns, diarrhoea, headaches, sore throats and wounds
1. Lavender flower oil for pain relief (Sheikhan, 2012)(250) 2. Lavender flower oil for episiotomy during recovery (Vakilian, 2011) (249)
Lemon oil (Limonis aetheroleum) 01/2008:0620Essential oil obtained by suitable mechanical means, without
the aid of heat, from the fresh peel of Citrus limon (L.) Burman fil.
Lemon Verbena Leaf (Verbenae citriodorae folium) 01/2012:1834Whole or fragmented, dried leaves of Aloysia citrodora Paláu
(syn. Aloysia triphylla (L’Hér.) Kuntze; Verbena triphylla L’Hér.; Lippia citriodora Kunth).
– acteoside (C29H36O15 ; Mr 625) : minimum 2.5 per cent,
expressed as ferulic acid (dried drug);
– essential oil: minimum 3.0 mL/kg for the whole drug and
minimum 2.0 mL/kg for the fragmented drug (dried drug).
1. Lemon verbena leaf and its function as supplementation on muscular damage markers, proinflammatory cytokines release and other neurology sicknesses in chronic exercise (Funes, 2011)(253) 2. Study of lemon verbena leaf and fish oil omega-3 fatty acid as joint management (Caturla, 2011)(254) 3. Lemon verbena leaf as a supplementation for multiple sclerosis patients (Mauriz, 2014)(252) 4. Lemon verbena leaf as an antioxidant (Carrera-Quintanar, 2012)(255)
Lime flower (Tiliae flos) 01/2008:0957Whole, dried inflorescence of Tilia cordata Miller, of Tilia platyphyllos Scop., of Tilia ×vulgaris Heyne or a mixture of these.
Indication 1)
Traditional herbal medicinal product used for the
relief of symptoms of common cold.
Indication 2)
Traditional herbal medicinal product for the relief
of mild symptoms of mental stress.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
1. Lime flower as a inhibitor of Fe absorption and can reduce absorption in a dose-dependent fashion depending on the content of total polyphenols (Hurrlel, 1999)(256)
Linseed (Lini semen) 04/2011:0095Dried, ripe seeds of Linum usitatissimum L.Traditional herbal medicinal product used as a
demulcent preparation for the symptomatic relief
of mild gastrointestinal discomfort.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use
Herbal medicinal product for the treatment of habitual constipation or in conditions in which easy defaecation with soft stool is desirable.1. Linseed as part of a medicine that can reduce blood pressure (Khalesi, 2015)(258) 2.Linseed as tester for pork and pork products (Corino, 2014)(261) 3. Linseed as a part of an additive of methane-mitigating effect (Guyader, 2015)(259) 4. Survey of omega 3 fatty acid for the prevention of cognitive decline and dementia (Sydenham, 2012)(257) 5. Meta-analysis of linseed oil as a supplement (and fatty acid composition) of cow milk (Glasser, 2008)(260) 6. Linseed oil as an additive in dietary in older adults (Avelino, 2015) (262)
Liquorice dry extract for flavouring purposes (Liquiritiae extractum siccum ad saporandum) 01/2012:2378Dry extract produced from Liquorice root (0277).5.0 per cent to 7.0 per cent of 18β-glycyrrhizic acid (C42H62O16 ; Mr 823) (dried extract).
Liquorice ethanolic liquid extract, standardised (Liquiritiae extractum fluidum ethanolic normatum) 01(2012:1536Standardised ethanolic liquid extract produced from Liquorice
root (0277).
3.0 per cent to 5.0 per cent of 18β-glycyrrhizic acid
(C42H62O16 ; Mr 823)
Liquorice root (Liquiritiae radix) 01/2012:0277Dried, unpeeled or peeled, whole or cut root and stolons of Glycyrrhiza glabra L. and/or of Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch.minimum 4.0 per cent of 18β-glycyrrhizic acid (C42H62O16 ; Mr 823) (dried drug).Traditional useNoneAs a demulcent in the treatment of sore throats, and as an expectorant in the treatment of coughs and bronchial catarrh. Also in the prophylaxis and treatment of gastric and duodenal ulcers, and dyspepsia. As an anti-inflammatory agent in the treatment of allergic reactions, rheumatism and arthritis, to prevent liver toxicity, and to treat tuberculosis and adrenocorticoid insufficiency. As a laxative, emmenagogue, contraceptive, galactagogue, antiasthmatic drug, and antiviral agent . In the treatment of dental caries, kidney stones, heart disease, "consumption", epilepsy, loss of appetite, appendicitis, dizziness, tetanus, diphtheria, snake bite, and haemorrhoids""s a demulcent in the treatment of sore throats, and as an expectorant in the treatment of coughs and bronchial catar"1. Liquorice root proof that can be a potent cariostatic agent in pediatric field (Jain, 2013) (266) 2. Survey of new tonic for a dry, itchy and subclinical inflamed scalp treatment (Schweiger, 2013)(264) 3. Study of a traditional Chinese herbal medicine in two different cytochrome enzymes (P450) (Saruwatari, 2003)(265) 4. Study of liquorice root as an antioxidant during aging a type of muscle in Tan sheep (Zhang, 2015)(263)
Long Pepper (Piperis longi fructus) 07/2014:2453Dried, ripe or nearly ripe fruiting spikes of Piper longum L. or Piper retrofractum Vahl (syn. P. chaba Hunter and
P. officinarum (Miq.) C.DC.) or a mixture of both species.
– essential oil: minimum 6.0 mL/kg (dried drug);
– piperine (C17H19NO3 ; Mr 285.3) : minimum 3.0 per cent (dried drug).
Loosestrife (Lythri herba) 04/2013:1537Dried flowering tops, whole or cut, of Lythrum salicaria L.minimum 5.0 per cent of tannins, expressed as
pyrogallol (C6H6O3 ; Mr 126.1) (dried drug).
1. Review about Loosestrife plant; general information and different uses (Piwowarski, 2015)(267)
Lovage Root (levistici radix) 01/2013:1233Whole or cut, dried rhizome and root of Levisticum officinale Koch.minimum 4.0 mL/kg of essential oil for the whole drug and minimum 3.0 mL/kg of essential oil for the cut drug (dried drug).
Magnolia officinalis Bark (Magnoliae officinalis cortex) 04/2014:2567Dried bark from the stem and branch of Magnolia officinalis Rehder et E.H. Wilson.minimum 2.0 per cent for the sum of magnolol (C18H18O2 ; Mr 266.3) and honokiol (C18H18O2 ; Mr 266.3) (dried drug).Used orally for the treatment of gastrointestinal disorders such as constipation,
dyspepsia, gastritis, nausea and vomiting. Also used orally to treat
anxiety, coughs and shortness of breath
Treatment of allergic rhinitis, headache, lack of appetite, respiratory congestion,
neurosis and fever, and as a uterine stimulant
1. Magnolia bark as a content on a gum that causes caries and gingivitis (Campus, 2011)(269) 2. Magnolia bark and zinc lactate can reduce the oral VSC level for two hours (Porciani, 2014)(268) MAGNOLIA EXTRACT 1. Magnolia extract in dentrific reduces gengivitis in a significatly way (Hellström, 2014)(270)
Magnolia officinalis flower (Magnoliae officinalis flos) 01/2013:2568Steamed and dried, unopened flower of Magnolia officinalis Rehder et E.H. Wilson.minimum 0.20 per cent of the sum of magnolol (C18H18O2 ; Mr 266.3) and honokiol (C18H18O2 ; Mr 266.3) (dried drug).
Majoram (Origani majoranae herba)1. Majoram is a safe tool for limiting recurrence of CMD (widespread dermatitis in dogs) (Nardoni, 2014) (271)
Malabar-nut leaf (Adhatodae vasicae folium)1. KJ as a therapeutic use for upper respiratory tract infection (Barth, 2015)(272)
Mallow Flower (Malvae sylvestris flos) 01/2011:1541Whole or fragmented dried flower of Malva sylvestris L. or its cultivated varieties.1. Mallow flower, information and uses in general (Gasparetto, 2012)(274) 2. Mallow flower for phytotherapy (Guarrera, 2005)(273) 3. Mallow flower for functional constipation (Elsagh, 2015)(275)
Mallow Leaf (Malvae folium) 07/2011:2391Whole or fragmented, dried leaf of Malva sylvestris L., Malva
neglecta Wallr. or a mixture of both species.
Dry cough; irritation of the oral, pharyngeal or gastric mucosa [6, 13, 14].
Mandarin Epicarp and Mesocarp (Citri reticulatae epicarpium et mesocarpium) 04/2016:2430Dried epicarp and mesocarp of the ripe fruit of Citrus reticulata Blanco or its cultivars, partly freed from the white spongy tissue of the mesocarp.minimum 3.5 per cent of hesperidin (C28H34O15 ; Mr 611) (dried drug).
Mandarin oil (Malvae folium) 07/2011:2391Essential oil obtained without heating, by suitable mechanical treatment, from the peel of the fresh fruit of Citrus reticulata Blanco.1. Study of mandaril oil used after craniofacial surgery on infants in a massage for reduce distress (de Jong, 2012) (276)
Marigold (Calendulae herba)· · ·· · ·
Marshmallow Leaf (Althaeae folium) 01/2012:1856Whole or cut, dried leaf of Althaea officinalis L.Traditional herbal medicinal product for use as a
demulcent preparation
a) for the symptomatic treatment of oral or
pharyngeal irritation and associated dry cough
b) for the symptomatic relief of mild
gastrointestinal discomfort
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use
Marshmallow Root (Althaeae radix) 01/2012:1126Peeled or unpeeled, whole or cut, dried root of Althaea
officinalis L.
Traditional herbal medicinal product for use as a
demulcent preparation
a) for the symptomatic treatment of oral or
pharyngeal irritation and associated dry cough
b) for the symptomatic relief of mild
gastrointestinal discomfort
The product is a traditional herbal medicinal
product for use in specified indications exclusively based upon long-standing use.
NoneAs a demulcent for symptomatic treatment of dry irritable coughs and irritations of oral and pharyngeal mucosa and as an emollient for wounds and dry skin. Also used in cough mixtures to mask the bitter or pungent taste of other drugs. Treatment of asthma, cystitis, dysentery and irritations of the gastric mucosaDry cough; irritation of the oral, pharyngeal or gastric mucosa [15, 20-28].1. Can Thyme and ivy syrup be a combinel herbal for cough and be efficient? (Büechi, 2005)(23)
Mastic (mastix) 01/2008:1876Dried resinous exudate obtained from stems and branches of Pistacia lentiscus L. var. latifolius Cossminimum 10 mL/kg of essential oil (anhydrous drug).
Mastic tree resin (Pistacia lentiscus, resinum (mastix))1. Mastic tree resin as a powder could have hepatopretective7cardioprotective role in vivo in humans (Triantafyllou, 2007) (277) 2. Study of proving that Mastic gum is effective in the treatment of functional dyspepsia (Dabos, 2010) (279) 3. Herbal plants used for the treatment of abnormal uterine bleeding caused by Avicenna (Mobli, 2015)(278)
Maté Leaf (Mate folium)Indication 1)
Traditional herbal medicinal product for symptoms
of fatigue and sensation of weakness.
Indication 2)
Traditional herbal medicinal product to increase
the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary
complaints.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
1. Maté leaf as a herbal plant for weight loss and delayed gastric emptying jus like a souht american herbal preparation says (Andersen, 2001)(203)
Matricaria Flower (Matricariae flos) 04/2016:0404Dried capitula of Matricaria recutita L. (Chamomilla
recutita (L.) Rauschert).
– blue essential oil: minimum 4 mL/kg (dried drug);
– total apigenin 7-glucoside (C21H20O10 ; Mr 432.4) : minimum
0.25 per cent (dried drug).
· · ·· · ·1. Matricaria chamomilla for treating against anisakiasis (Romero, 2012)(281) 2. Matricaria flower as a dietary supplement for dysmenorrhoea (Pattanittum, 2016)(101) 3. Matricaria flower as a being part of the treatment of functional dyspepsia (Madisch, 2004) (280) MATRICARIA CHAMOMILLA 1. Matricaria chamomilla oil for knee osteoarthritis (Shoara, 2015) (99)
Matricaria liquid extract (Matricariae extractum fluidum) 01/2008:1544Liquid extract produced from Matricaria flower (0404).Content: minimum 0.30 per cent of blue residual oil.
Matricaria Oil (Matricariae aetheroleum) 01/2008:1836Blue essential oil obtained by steam distillation from the
fresh or dried flower-heads or flowering tops of Matricaria recutita L. (Chamomilla recutita L. Rauschert). There are 2 types of matricaria oil (characterised as rich in bisabolol oxides, or rich in (−)-α-bisabolol.)
Meadowsweet (Filipendulae ultimariae herba) 04/2013:1868Whole or cut, dried flowering tops of Filipendula ulmaria (L.) Maxim. (syn. Spiraea ulmaria L.).minimum 1 mL/kg of essential oil (dried drug).Indication 1)
Traditional herbal medicinal product for the
supportive treatment of common cold. Indication 2)
Traditional herbal medicinal product for the relief
of minor articular pain.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Filipendila is used as supportive therapy for the common cold [Schilcher 1992, Meier 1993, Wichtl 1997, Zeylstra 1998, Schulz 2001, Wichtl 2009]. Meadowsweet is also used to enhance the renal elimication of water [Decaux 1941, Leclerc 1976, Valnet 1976, Meier 1993, Wichtl 1997, 2009; Zeylstra 1998] although published scientific evidence does not adequately support this indication.1. Meadowsweet effect as an antiinflammatory (Drummond, 2013)(283) 2. Potential for adverse interactions with analgesic drugs (Abebe, 2002) (282)
Melilot (Meliloti herba) 07/2012:2120Whole or cut, dried aerial parts of Melilotus officinalis (L.) Lam.minimum 0.3 per cent of coumarin (C9H6O2 ; Mr 146.1) (dried drug).ORAL USE: 1. Traditional herbal medicinal product to relieve
symptoms of discomfort and heaviness of legs
related to minor venous circulatory
disturbances. CUTANEOUS USE: 2. Traditional herbal medicinal product to relieve
symptoms of discomfort and heaviness of legs
related to minor venous circulatory
disturbances.
3. Traditional herbal medicinal product for
symptomatic treatment of bruises and sprains. CUTANEOUS USE OF EMPLASTRUM MELILOTI 4. Traditional herbal medicinal product used for
symptomatic treatment of insect bites.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
1. Melilot investigation about tolenace to salinity and bacterial genetic determinants (Roumiantseva, --)(285) 2. Melilot review bout ist plasmid mobilme of the model pant-symbiont Sinorhizobium (Lagares, 2014)(284)
Melissa leaf (Melissae folium) 01/2011:1447Dried leaf of Melissa officinalis L.minimum 1.0 per cent of rosmarinic acid (C18H16O8 ;
Mr 360.3) (dried drug).
Indication 1)
Traditional herbal medicinal product for relief of
mild symptoms of mental stress and to aid sleep.
Indication 2)
Traditional herbal medicinal product for
symptomatic treatment of mild gastrointestinal
complaints including bloating and flatulence.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Externally, for symptomatic treatment of herpes labialisOrally as a carminative for gastrointestinal disorders, and as a sedative for treatment of nervous disturbances of sleep. Treatment of amenorrhoea, asthma, bee stings, coughs, dizziness, dysmenorrhoea, migraine headaches, tachycardia, toothache, tracheobronchitis and urinary incontinenceINTERNAL USE: Tenseness, restlessness and irritability, symptomatic treatment of digestive disorders such as minor spasms [Stahl-bisckup 2009, Fintelmann 2009]. EXTERNAL USE: Herpes labialis (cold sores) [Wölbling 1984, Vogt 1991, Wölbling 1994, Koytchev 1999].1. Melissa officinalis can relief heart palpitation (Alijaniha, 2015)(287) 2. Melissa officinalis and its traditional use, information in general (Shakeri, 2016)(289) 3. Valuation of melissa officinalis ' safety tolerability and pharmacokinetics in healthy humans (Noguchi-shinohara, 2015)(286) 4. Melissa officinalis and its effect to modulate the mood and cognitive performance on humans (Kennedy, 2003)(288)
Melissa leaf dry extract (Melissae folii extractum siccum) 01/2010:2524Dry extract produced from Melissa leaf (1447).minimum 2.0 per cent of rosmarinic acid (C18H16O8 ; Mr 360.3) (dried extract).
Milk Thistle Fruit (Silybi mariani fructus) 01/2014:1860Mature fruit, devoid of the pappus, of Silybum marianum L. Gaertner.minimum 1.5 per cent of silymarin, expressed as silibinin (C25H22O10 ; Mr 482.4) (dried drug).· · ·· · ·Supportive treatment of acute or chronic hepatitis and cirrhosis induced by alcohol, drugs or toxinsTreatment of dyspeptic complaints and gallstones, Treatment of amenorrhoea, constipation, diabetes, hay fever, uterine haemorrhages and varicose veins1. Milk thistle as a supplement on glycemin control (two types of diabetes)(Suksomboon, 2011)(292) 2. Milk thistle is tolerated (Silymarin) in chronic HCV-infected patients (Yang, 2014)(293) 3. Study of milk thistle fo alcoholic and(or hepatitis B or C live diseases (Rambaldi, 2005)(291) 4. Silymarin supplementation imporves some antioxidant indices and decrese hs-CRP levels in T2DM patients (Ebrahimpour Koujan, 2015)(290)
Milk thistle dry extract, refined & standardised (Silybi mariani extractum siccum raffinatum et normatum) 01/2014:2071Dry extract, refined and standardised, produced from Milk
thistle fruit (1860).
90 per cent to 110 per cent of the nominal content of silymarin, expressed as silibinin (C25H22O10 ; Mr 482.4), stated on the label. The nominal content of silymarin is within the range 30 per cent m/m to 65 per cent m/m (dried extract).
Mint oil, partly dementholised (Menthae arvensis aetheroleum partim mentholum depletum) 01/2008:1838Essential oil obtained by steam distillation from the fresh, flowering aerial parts, recently gathered from Mentha canadensis L. (syn. M. arvensis L. var. glabrata (Benth) Fern., M. arvensis var. piperascens Malinv. ex Holmes), followed by partial separation of menthol by crystallisation.
Mistletoe (Visci albi herba)· · ·· · ·1. Mistletoe as treatment for nonmuscle invasive bladder cancer patients (Rose, 2015)(297) 2. Cancer patients treated with mistletoe, a meta-analysis(Ostermann, 2012)(296) 3. Mistletoe as a treatment for non-small-cell lung cancer patients (Bar-Sela, 2013)(295) 4. Mistletoe as complement and alternative suppliment for cancer oatients (Shneerson, 2013)(298) 5. A review that exposes survivar patients that suffered cancer and were treated with mistletoe (Ostermann, 2009)(294)
Motherwort (Leonuri cardiacae herba) 01/2013:1833Whole or cut, dried flowering aerial parts of Leonurus cardiaca L.minimum 0.2 per cent of flavonoids, expressed as hyperoside (C21H20O12 ; Mr 464.4) (dried drug).Indication 1)
Traditional herbal medicinal product used to
relieve symptoms of nervous tension.
Indication 2)
Traditional herbal medicinal product used to
relieve symptoms of nervous cardiac complaints
such as palpitations, after serious conditions have
been excluded by a medical doctor.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
1. Motherwort as a part of ZTD (Ziyin Tongbi Decoction), efficient for benign prostatic hyperplasia treatment (Guo, 2008)(301) 2. Motherowrt injection to prevent postpartum hemorrhage (caesarian section) (Lin, 2009) (300) 3. Wild cannabis, information and uses un general (Nsuala, 2015)(302) 4. Compilation of the research of Salvia divinorum thorugh the years (Casselman, 2014)(299)
Mouse-ear hawkweed (Pilosellae herba cum radice)Traditional herbal medicinal product used to
increase the amount of urine to achieve flushing
of the urinary tract as an adjuvant in minor urinary tract complaints. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
Mullein Flower (Verbasci flos) 01/2011:1853Dried flower, reduced to the corolla and the androecium, of Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad), and V. phlomoides L.Herbal medicinal product traditionally used to relieve symptoms of sore throat associated with dry cough and cold. The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.Common cold associated with cough or sore throat as a demulcent and/or a mild expectorant [Bradley 2006, Blohme 2007, Schilcher 2008, Wichtl 2009]. In these indications, the efficacy is plausible on the basis of long-standing use.1. A review about advances on research in Mullein flower (Turker, 2005)(303)
Myrrh (Myrrha) 01/2008:1349Gum-resin, hardened in air, obtained by incision or produced by spontaneous exudation from the stem and branches
of Commiphora molmol Engler and/or other species of Commiphora.
Indication 1)
Traditional herbal medicinal product for treatment
of minor ulcers and inflammation in the mouth Indication 2) Traditional herbal medicinal product for treatment of minor wounds and small boils (furuncles). The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
As an emmenagogue, expectorant and antidote for poisons, and to inhibit
blood coagulation. Treatment of menopausal symptoms, arthritic
pain, diarrhoea, fatigue, headache, jaundice and indigestion, and applied
topically for treatment of burns and haemorrhoids
Tropical treatment of gingivitis, stomatitis (aphthous elcers), minor skin inflammations, minor wounds and abrasions, supportive treatment for pharyngitis, tonsillitis [Moeck 2007, Martinetz 1989, Bradley 1992, Hiller 2009, Sweetman 2011, Barnes 2007]1. Hypercholesterolemia and his treatment with Myrrh (Nohr, 2009)(306) 2. Myrrh mucoadhesive gel for aphthous stomatitis (Mansour, 2014)(305) 3. Myrrh as part of treatment of hypercholesterolemia (Szapary, 2003)(307) 4. Clinical trial about myrrh and its effect for schistosomiasis mansoni (Barakat, 2005)(304)
Myrrh, Tincture (Myrrthae tinctura) 01/2008:1877Tincture produced from Myrrh (1349).
Narrow-Leaved Coneflower Root (Echinaceae angustifoliae radix) 01/2008:1821Whole or cut underground parts of Echinacea angustifolia (D.C.).minimum 0.5 per cent of echinacoside (C35H46O20 ; Mr 786.5) (dried drug).Traditional herbal medicinal product for supportive treatment of common cold. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.Preparations of Radix Echinaceae are administered orally in supportive therapy for colds and infections of the respiratory and urinary tract . Beneficial effects in the treatment of these infections are generally thought to be brought about by stimulation of the immune responseTreatment of yeast infections, side-effects of radiation therapy, rheumatoid arthritis, and food poisoning1. Narrow-leaved coneflower study for treating common cold (Barrett, 2010)(308) 2. E. Purpurea with etravirine was safe and well tolerated in HIV-infected patients (Moltó, 2012)(310) 3. Can E. Angustifolia root have effect on infection with rhinovirus (Turner, 2005)(311) 4. KJ as a therapeutic use for upper respiratory tract infection (Barth, 2015)(309)
Neroli oil (Neroli aetheroleum) 01/2008:1175Neroli oil is obtained by steam distillation from the fresh flowers of Citrus aurantium L. subsp. aurantium L. (C. aurantium L. subsp. amara Engl.)
Nettle herb (Urticae herba)a) Traditional herbal medicinal product to
increase the amount of urine to achieve
flushing of the urinary tract as an adjuvant in
minor urinary complaints.
b) Traditional herbal medicinal product for
relief of minor articular pain
c) Traditional herbal medicinal product used in
seborrhoeic skin conditions
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
Nettle Root (Urticae radix) 01/2015:2538Dried, whole or fragmented underground parts of Urtica
dioica L. or Urtica urens L., their hybrids or their mixtures.
Indication 1)
Traditional herbal medicinal product for relief of
minor articular pain.
Indication 2)
Traditional herbal medicinal product to increase
the amount of urine to achieve flushing of the
urinary tract as an adjuvant in minor urinary
complaints.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Symptomatic treatment of lower urinary tract disorders (nocturia, polyuria, urinary retention) resulting from BPH stages I and II, as defined by Alken, in cases where diagnosis of prostate cancer is negativeAs a diuretic and for the treatment of rheumatism and sciatica. Treatment of asthma, coughs, dandruff, diabetes, diarrhoea, eczema, fever, gout, haemorrhoids, nose bleeds, scurvy, snakebites and tuberculosis. The plant has also been used to stop uterine bleeding after childbirth, increase lactation and promote hair growth, and as a vermifugeSymptomatic treatment of micturirion disorders (dysuira, pollakisuria, nocturia, urine retention) in benign prostatic hyperplasia (BPH) [Djulepa 1982, Tosch 1983, Schilcher 1988a,b 1989, 1992; Stahl 1984, Vontobel 1985, Vahlensieck 1986, 1996; Vandierendounck 1986, Dathe 1987, Maar 1987, Bauer 1988, Feiber 1988, Friesen 1988, Goetz 1989, Jaspersen-Schib 1989, Belaiche 1991, Fischer 1992, Kaldewey 1995, Brom 1996, Engelmann 1996, Bracher 1997, veit 1998, Chrubasik 2007, Pagano 2014] at stages I and II as defined by Alken [Alken 1973] or stages II and III as defined by Vahlensieck [Vahlensieck 1996]1. Nettle root as an herb for treating osteoarthritis (Cameron, 2013)(312) 2. Nettle root administration and cytokine secretion in whole blood o healthy subjects (Teucher, 1996)(315) 3. Nettle root as being part of a successful pathogen that rapidly process that envolved fom emerging to endemic in tomata crops (Hanssen, 2010)(313) 4. Nettle root improves glycemic controls with patients with 2 types of diabetes (Kianbakht, 2013)(314)
Nettle Leaf (Urticae folium) 01/2011:1897Whole or cut dried leaves of Urtica dioica L., Urtica urens L., or a mixture of the 2 species.minimum 0.3 per cent for the sum of caffeoylmalic acid and chlorogenic acid, expressed as chlorogenic acid (C16H18O9 ; Mr 354.3) (dried drug).Indication 1)
Traditional herbal medicinal product for relief of
minor articular pain.
Indication 2)
Traditional herbal medicinal product to increase
the amount of urine to achieve flushing of the
urinary tract as an adjuvant in minor urinary
complaints.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Niaouli oil, cineole type (Niaouli typo cineolo aetheroleum) 07/2012:2468Essential oil obtained by steam distillation from young leafy
branches of Melaleuca quinquenervia (Cav.) S.T.Blake.
Notoginseng Root (Notoginseng radix) 01/2008:2383Whole or fragmented taproot, without secondary roots, of Panax pseudoginseng Wall. var. notoginseng (Burk.) Hoo et Tseng [Panax notoginseng (Burk.) F.H. Chen ex C.Y. Wu et K.M. Feng] treated with steam and dried.minimum 3.8 per cent for the sum of ginsenosides Rg1 (C42H72O14,2H2O ; Mr 837) and Rb1 (C54H92O23,3H2O ; Mr 1163) (dried drug).1. Notoginseng root as a substance of coronary angina pectoris treatment (Yuan, 1997)(319) 2. Ischemic stroke treatment via Notoginseng extract (He, 2011)(316) 3. CSP(Compund salvia pellet) can have an effect on the imporvement of angina symptoms and ECG results with few adverse events (Wang, 2006)(318) 4. Summarize of Notoginseng root and its distribution in different medical organs and pharmacological actions on cardiovascular system (Li, 2015)(317)
Nutmeg oil (Myristicae fragantis aetheroleum) 01/2008:1552Essential oil obtained by steam distillation of the dried and
crushed kernels of Myristica fragrans Houtt
Oak Bark (Quercus cortex) 01/2008:1887Cut and dried bark from the fresh young branches of Quercus robur L. Q. Petraea (Matt.) Liebl. and Q. pubescens Willd.minimum 3.0 per cent of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1) (dried drug).Indication 1)
Traditional herbal medicinal product for
symptomatic treatment of mild diarrhoea.
Indication 2)
raditional herbal medicinal product for
nt of minor inflammation of the oral mucosa or skin. Indication 3) Traditional herbal medicinal product for symptomatic relief of itching and burning associated with haemorrhoids, after serious conditions have been excluded by a medical doctor. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
1. MMP-2 assessment as an indicator of wound healing (Karim, --)(322) 2. Wound healing occured by cosmeceuticals and natural products (Davis, 2009)(320) 3. Oak bark and its treatment of diabetic foot ulcers (Jacobs, 2008)(321)
Oat Fruit (Avenae fructus)Traditional herbal medicinal product for the symptomatic treatment of minor inflammations of the skin (such as sunburn) and as an aid in healing of minor wounds. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.1. Study of oats in a celiac children dietary (Gatti, 2013)(323) 2. IO(instant oatmeal) and SO(old-fashioned oatmeal) can improve appetite control and oatmeal viscosity can be important for reducing appetite (Rebello, 2014)(324) 3. Can oatmeal porridge have an imoact on microflora-associated characteristics in healthy subjects? (Valeur, 2016) (325)
Oat Herb (Avenae herba)Traditional herbal medicinal product for relief of
mild symptoms of mental stress and to aid sleep.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
Olive Leaf (Oleae folium) 01/2009:1878Dried leaf of Olea europaea L.minimum 5.0 per cent of oleuropein (C25H32O13 ; Mr 540.5) (dried drug).Traditional herbal medicinal product used to
promote the renal elimination of water, in mild cases of water retention after serious conditions
have been excluded by a medical doctor.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
1. Comparation with captopril and olive leaf extract for patients with stage-1 hypertension (Susalit, 2011)(329) 2. Oilve leaf can have improvement in human vascular funtion and reduce cytokine inflammation (Lockyer, 2015)(328) 3. Olea europaea on pain in gonarthrosis (Takeda, 2013)(330) 4. Can olive leaf polyphenols improve insulin sensitivity middle-aged and overweight men? (de Bock, 2013)(326) 5. Olive leaf won't affect the oxidative status of healthy young adults (Kendall, 2009) (327)
Olive leaf dry extract (Oleae folii extractum siccum) 04/2009:2313Dry extract produced from Olive leaf (1878).minimum 16.0 per cent of oleuropein (C25H32O13 ; Mr 540.5) (dried extract).
Onion (Allii cepae bulbus)The principal use of Bulbus Allii Cepae today is to prevent age-dependent changes in the blood vessels, and loss of appetiteTreatment of bacterial infections such as dysentery, and as a diuretic . The drug has also been used to treat ulcers, wounds, scars, keloids , and asthma. Bulbus Allii Cepae has also been used as an adjuvant therapy for diabetes . As an anthelminthic, aphrodisiac, carminative, emmenagogue, expectorant, and tonic , and for the treatment of bruises, bronchitis, cholera, colic, earache, fevers, high blood pressure, jaundice, pimples, and sores.1. Survey about onion consuption can reduce risk for gastric cancer (Zhou, 2011)(335) 2. Onion can have effect of a quercetin-rich onion skin extract on 24h ambulatory blood pressure and endothelial function in overweight to obese patients with hypertension (Brüll, 2015)(331) 3. Study of onions have antidiabetic effect (Kook, 2009)(332) 4. Allium vegetable consuption can reduce gastric cancer risk (Turati, 2015)(334) 5. Silicone gel sheeting can work as a prevention fo abnormal scarring (O'Brien, 2013)(333)
Opium dry extract, Standardised (Opii extractum siccum normatum) 01/2015:1839Standardised dry extract produced from Raw opium (0777).– morphine (C17H19NO3 ; Mr 285.3) : 19.6 per cent to 20.4 per cent (dried extract);
– codeine (C H NO ; M 299.4): minimum 2.0 per cent 18 21 3 r
(dried extract).
1. Opium as an adjunt theraphy to opioids for neonatal abstinence syndrome (Agthe, 2009)(336) 2. Study and comparation between ipium tincture and methadone to control opioid with drawal in a Thai treatment centre (Jittiwutikarn, 2004)(337)
Opium, Prepared (Oppi pulvis normatus) 01/2015:1840Raw opium (0777) powdered (180) (2.9.12) and dried at a temperature not exceeding 70 °C, with a morphine content adjusted, if necessary, by adding a suitable excipient or raw opium powder with a lower alkaloidal content.– morphine (C17H19NO3 ; Mr 285.3) : 9.5 per cent to 10.5 per
cent (dried preparation);
– codeine (C18H21NO3 ; Mr 299.4) : minimum 1.0 per cent
(dried preparation).
Opium, Raw (Opium crudum) 01/2015:0777Air-dried latex obtained by incision from the unripe capsules
of Papaver somniferum L.
– morphine (C17H19NO3 ; Mr 285.3) : minimum 10.0 per cent (dried drug);
– codeine (C18H21NO3 ; Mr 299.4) : minimum 2.0 per cent (dried drug).
Opium tincture, Standardised (Opii tinctura normata) 01/2015:1841Standardised tincture produced from Raw opium (0777).– morphine (C17H19NO3 ; Mr 285.3) : 0.95 per cent to 1.05 per
cent ;
– codeine (C18H21NO3 ; Mr 299.4) : minimum 0.1 per cent.
1. Study that compares and proves that opium tincture with phenobarbital will have better neurobehavioral scores than infants treated with opium tincture alone (Coyle, 2005)(338) 2. Opium tincture its general information and application/uses (Somogyi, 2008)(339)
Oregano (origani herba) 01/2011:1880Dried leaves and flowers separated from the stems of
Origanum onites L. or Origanum vulgare L. subsp. hirtum (Link) Ietsw., or a mixture of both species.
– essential oil: minimum 25 mL/kg (anhydrous drug);
– sum of the contents of carvacrol and thymol (both C10H14O; Mr 150.2): minimum 60 per cent in the essential oil.
1. Oregano applicaten on a dietary based on it as a supplement (Simitzis, 2010)(342) 2. Oregano for controling of proliferative enteropathy in weaning pigs (Papatsiros, 2009)(341) 3. Thymol andits antibacterial and antifungal activities (Marchese, 2016)(340)
Orientvine Stem (Sinomenii caulis) 01/2013:2450Dried, whole or fragmented stem of Sinomenium acutum (Thunb.) Rehder et E.H.Wilson, collected in late autumn and early winter.minimum 0.5 per cent of sinomenine (C19H23NO4 ; Mr 329.4) (dried drug).
Pale Coneflower Root (Echinaceae pallidae radix) (01/2008:1822Dried, whole or cut underground parts of Echinacea pallida Nutt.minimum 0.2 per cent of echinacoside (C35H46O20 ; Mr 786.5) (dried drug).Traditional herbal medicinal product for
supportive treatment of common cold.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Passion Flower (Passiflorae herba) 01/2008:1459Fragmented or cut, dried aerial parts of Passiflora incarnata L. It may also contain flowers and/or fruits.minimum 1.5 per cent of total flavonoids, expressed as vitexin (C21H20O10 ; Mr 432.4) (dried drug).Traditional herbal medicinal product for relief of
mild symptoms of mental stress and to aid sleep.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Internally as a mild sedative for nervous restlessness, insomnia and anxiety.
Treatment of gastrointestinal disorders of nervous origin
As an anodyne, antispasmodic and mild stimulant. Treatment of
dysmenorrhoea, neuralgia and nervous tachycardia
1. Passion flower as a reducer of anxiety for peroperative patients (Movefagh, 2008)(345) 2. Passiion flower can work as an anxiolytic for previous spiral anethesia surgery (Aslanargun, 2012)(343) 3. Passiflora for anxiety disroders (Miyasaka, 2007)(344) 4. Passiflora (tea) effect on subjective sleep quality (Ngan, 2011)(346)
Passion flower, dry extractum (Passioflorae herbae extractum siccum) 01/2008:1882Dry extract produced from Passion flower (1459).minimum 2.0 per cent of flavonoids, expressed as vitexin (C21H20O10 ; Mr 432.4) (dried extract).
Pelargonium Root (Pelargonii radix) 01/2008:2264Dried, usually fragmented, underground organs of Pelargonium sidoides DC and/or Pelargonium renidorme Curt.minimum 2.0 per cent of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1) (dried drug).Traditional useSymptoms of upper respiratory tract infections including common cold, such as blocked or runny nose, sore throat and cough [Timmer 2013, kamin 2010a-b, Brendler 2009, Bachert 2009, Agbabiaka 2008, Matthys 2010a/ 2007c/2003, Lizougub 2007, Chuchalin 2005, Bereznoy 2003].1. Pelargonium for treating acute respiratory tracty infections (Timmer, 2013)(351) 2. Immune responses induced by Pelargonium extract (Luna, 2011)(348) 3. Pelargonium root for resolving symptoms associated with common cold in adults (Ross, 2012)(349) 4. Acute bronchitis can be solved with pelargonium root (Agbabiaka, 2008)(347) 5. Pelargonium root and it effect on EPs ® 7630 prevent asthma attacks (Tahan, 2013)(350) 6. Is pelargonium root affective against acute bronchitis? (Schlz, 2007)(353) 7. Pelargonium sidoides intervention in upper respiratory tract infections treatment in children (Patiroglu, 2012)(352)
Peony Root, Red (Paeoniae radix rubra) 01/2017:2425Dried, whole or fragmented root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch or a mixture of the two, with rhizome and rootlets removed.minimum 1.8 per cent of paeoniflorin (C23H28O11 ; Mr 480.5) (dried drug).NoneAs an analgesic, anti-inflammatory and antispasmodic drug in the treatment of amenorrhoea, dysmenorrhoea, and pain in the chest and abdomen. Radix Paeoniae is also used to treat dementia, headache, vertigo, spasm of the calf muscles , liver disease, and allergies, and as an anticoagulant. The treatment of atopic eczema, boils, and sores; to reduce fevers, induce sterility, and treat burns 1. Peony root structure for treatment of insomnia (Zhou, 2011)(357) 2. Peony root can reduce hepatotoxicity by total glucosides (Chen, 2013)(354) 3.The relation between clinical effects of Tokishakuyakusan and the identity of Paeonia lactiflora materials (Shimada, 2010)(356) 4. Constituents of Peony root, structure information in general (Parker, 2016)(355)
Peony Root, White (Paeoniae radix alba) 01/2017:2424Whole or fragmented, peeled root, of Paeonia lactiflora Pall. with rhizome and rootlets removed, treated with boiling water and dried.minimum 1.6 per cent of paeoniflorin (C23H28O11 ; Mr 480.5) (dried drug).NoneAs an analgesic, anti-inflammatory and antispasmodic drug in the treatment of amenorrhoea, dysmenorrhoea, and pain in the chest and abdomen. Radix Paeoniae is also used to treat dementia, headache, vertigo, spasm of the calf muscles , liver disease, and allergies, and as an anticoagulant. The treatment of atopic eczema, boils, and sores; to reduce fevers, induce sterility, and treat burns1. Peony root structure for treatment of insomnia (Zhou, 2011)(357) 2. Peony root can reduce hepatotoxicity by total glucosides (Chen, 2013)(354) 3.The relation between clinical effects of Tokishakuyakusan and the identity of Paeonia lactiflora materials (Shimada, 2010)(356) 4. Constituents of Peony root, structure information in general (Parker, 2016)(355)
Pepper (Piperis fructus) 01:2013:2477Dried, ripe or nearly ripe fruit of Piper nigrum L. with an unbroken pericarp (black pepper) or with the outer layers of the pericarp removed (white pepper).– essential oil: minimum 25 mL/kg (anhydrous drug);
– piperine (C17H19NO3 ; Mr 285.3) : minimum 3.0 per cent (anhydrous drug).
BLACK PEPPER 1. Review and meta-analysis about if capsaicinoids help to support weight management (Whiting, 2014)(361) 2. Effecfts of black pepper on sustained attention and on energy and fatigue mood (Lindheimer, 2013)(359) 3. Neck pain solution (Ou, 2014)(360) 4. Energy expenditure, appetite ad libitum energy intake and energy balance in human subjects (Gregersen, 2013)(358) WHITE PEPPER 1. Can white ppepr treat diarrhea in infants and children? (Jin, 2013)(362)
Peppermint (Menthae piperitae aetheroleum)OMS: essential oil obtained by steam distillation of the fresh overground parts of Mentha × piperita L. (Lamiaceae) (1-4).Traditional herbal medicinal product
• Cutaneous and transdermal use
1. For the relief of symptoms in coughs and
colds
2. For the symptomatic relief of localised
muscle pain
3. For the symptomatic relief of localised
pruritic conditions in intact skin
• Inhalation
4. For the relief of symptoms in coughs and
colds
• Oromucosal use
5. For the relief of symptoms in coughs and
colds
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
• Oral use
1. Herbal medicinal product for the
symptomatic relief of minor spasms of the
gastrointestinal tract, flatulence and
abdominal pain, especially in patients with
irritable bowel syndrome.
• Cutaneous use
2. Herbal medicinal product for the
symptomatic relief of mild tension type
headache.
Internally for symptomatic treatment of irritable bowel syndrome, and digestive disorders such as flatulence and gastritis. Externally for treatment of myalgia and headacheInternally and externally for the symptomatic treatment of catarrh and coughs. Treatment of dysentery, diabetes, dysmenorrhoea, fevers, jaundice and urinary infections1. Peppermint oil for treatment of irrtable bowel syndrome (Khanna, 2013)(364) 2. Peppermint oil and its effect when administration on gastric sensorimotos function and nutrient tolerance (Papathanasopoulos, 2013)(367) 3. The effect of peppermint oil on irritable bowel syndrome (Merat, 2010)(365) 4. Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms (Cash, 2016)(363) 5. Study of modulation of cognitive performance and mood by aramas (Moss, 2008)(366)
Peppermint leaf (Menthae piperitae folium) 01/2011:0406Whole or cut dried leaves of Mentha ×piperita L.minimum 12 mL/kg of essential oil for the whole drug and minimum 9 mL/kg of essential oil for the cut drug.Traditional herbal medicinal product for the
symptomatic relief of digestive disorders such as
dyspepsia and flatulence.
The product is a traditional herbal medicinal
product for use in specified indication exclusively
based upon long-standing use.
Internally for symptomatic treatment of irritable bowel syndrome and digestive disorders such as flatulence and gastritis. Externally for treatment of myalgia and headacheInternally and externally for the symptomatic treatment of catarrh and coughs. Treatment of dysentery, diabetes, dysmenorrhoea, fevers, jaundice and urinary infections
Peppermint leaf dry extract (Menthae piperitae folii extractum siccum) 04/2009:2382Dry extract produced from Peppermint leaf (0406).minimum 0.5 per cent of rosmarinic acid (C18H16O8 ; Mr 360.33) (dried extract)
Peppermint oil (Menthae piperitae aetheroleum) 07/2012:0405Essential oil obtained by steam distillation from the fresh
aerial parts of the flowering plant of Mentha ×piperita L.
CUTANEOUS AND TRANSDERMAL USE: 1. For the relief of symptoms in coughs and colds 2. For the symptomatic relief of localised muscle pain 3. For the symptomatic relief of localised pruritic conditions in intact skin INHALATION 4. For the relief of symptoms in coughs and colds • OROMUCOSAL USE 5. For the relief of symptoms in coughs and colds. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
Peru balsam (Balsamum peruvianum) 01/2008:0754Balsam obtained from the scorched and wounded trunk of Myroxylon balsamum L. Harms var. Pereirae (Royle) Harms.45.0 per cent m/m to 70.0 per cent m/m of esters, mainly benzyl benzoate and benzyl cinnamate.1. Retrospective of presistence in leg ulcer patients trest (Machet, 2004)(370) 2. Study of a dark test-substance pigemntation on skin perfusion assessments of peru balsam (Bjarnason, 2000)(368) 3. Relation about vitro cyclic adenosine monophosphate phosphodiesterase inhibition and in vivo anti-inflammatory effect (Goyarts, --)(369)
Pine sylvestris oil (Pini sylvestris aetheroleum) 01/2008:1842Essential oil obtained by steam distillation of the fresh leaves and branches of Pinus sylvestris L. A suitable antioxidant may be added.
Pink rock-rose (Cisti cretici folium)
Polygonum cuspidatum Rhizome and root (Polygoni cuspidati rhizoma et radix) 01/2017:2724Dried, fragmented rhizome and root, with rootlets removed, of Reynoutria japonica Houtt. (syn. Polygonum cuspidatum Sieb. et Zucc.) collected in spring or autumn.– emodin (C H O ; M 270.2): minimum 1.0 per cent (dried
– polydatin (C20H22O8 ; Mr 390.4) : minimum 1.5 per cent (dried drug).
1. Study of antibacterial activity and action between Polygonum cuspidatum and haemophilus parasius (in vitro) (Li, 2016)(373) 2. Polygonum cuspidatum and his effect as antiinflammatory and reactive oxugen species (Ghanim, 2010)(372) 3. Polygonum cuspidatum and its general information(Fan, 2013)(371)
Polygonum orientale fruit (Polygoni orientalis fructus) 01/2017:2726Dried ripe fruit of Persicaria orientalis (L.) Spach (syn. Polygonum orientale L.).minimum 0.15 per cent of taxifolin (C15H12O7 ; Mr 304.3) (dried drug).
Polypody rhizome (Polypodii rhizoma, Polypodium vulgare)a) Traditional herbal medicinal product used as
an expectorant in cough and cold.
b) Traditional herbal medicinal product for
short-term use in cases of occasional
constipation.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
Poria (Poria) 07/2012: 2475Dried sclerotium without skin of Wolfiporia extensa (Peck) Ginns (syn. Poria cocos (Schw.) Wolf; Wolfiporia cocos (F.A. Wolf) Ryvarden & Gilb.).1. Poria beinh part of an treatment that can have an effect on depressive patients (Tian, 2014)(377) 2. Poria, general information (pharmacokinetics) (Kitagawa, 2015)(376) 3. Osteoporosis treatment study via chinese medicine (Gao, 2013)(375) 4. FOLFOX 4 and herbal medicine for colorectal cancer (Chen, 2014)(374)
Primula flower (Primulae flos)Traditional herbal medicinal product used as an
expectorant in cough associated with cold.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Primula Root (Primulae radix) 04/2013:1364Whole or cut, dried rhizome and root of Primula veris L. or
Primula elatior Hill.
Traditional herbal medicinal product used as an expectorant in cough associated with cold. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing useProductive cough [17, 18]; catarrh of the respiratory tract [17, 19]; chronic bronchitis [12, 17, 18].
Primrose oilPrimrose oil for eczema (Bamford, 2013)(377) 2.Effect of environmental factors on risk of injury of child pedestrians by motor vehicles (Roberts, 1995)(381) 3. Primrose oil for dietary supplement, involved in atopic eczema (Bath-Hextall, 2012)(379) 4.Placebo-controlled trial of essential fatty acid supplementation in atopic dermatitis (Berth-Jones, 1993)(380)
Psyllium Seed (Psylli semen) 01/2008:0858Ripe, whole, dry seeds of Plantago afra L. (Plantago
psyllium L.) or Plantago indica L. (Plantago arenaria Waldstein and Kitaibel).
Indication 1)
Herbal medicinal product for the treatment of
habitual constipation.
Indication 2)
Herbal medicinal product in conditions in which easy defecation with soft stool is desirable, e.g. in
cases of painful defecation after rectal or anal
surgery, anal fissures and haemorrhoids.
As a bulk-forming laxative used to restore and maintain regularity. Semen Plantaginis is indicated in the treatment of chronic constipation, temporary constipation due to illness or pregnancy, irritable bowel syndrome, constipation related to duodenal ulcer or diverticulitis. It is also used to soften the stools of those with haemorrhoids, or after anorectal surgeryWhile Semen Plantaginis is primarily used in the treatment of constipation, it has also been used effectively in the short-term symptomatic treatment of diarrhoea of various etiologies. Other medical uses claimed for Semen Plantaginis include use as an expectorant and antitussive, an antibacterial agent, and a diuretic and in the treatment of rheumatic and gouty afflictions, glandular swelling, and bronchitisTreatment of occasional constipation. Conditions in which easy defecation with soft stools is desirable, e.g. In cases of anal fissures of haemorrhoids, after rectal or anal surgery, and during pregancy [3, 7, 8]. Adjuvant symptomatic therapy in cases of diarrhoea from various causes [9].PSYLLIUM 1. Research of Psyllium and its effect on cholesterol related (Olson, 1997)(382) 2. Viscosity is better than quantity (on a dieatry fibre, predicts reducing cholesterol effect in healthy individuals ) (Vuksan, 2001)(383) PSYLLIUM SEED 1. Dose and time of psyllium can make a difference on moderate hypercholesterolemia (Wei, 2009)(387) 2. The effect of psyllium on lipoproteins on diabetic patients (type II) (Sartore, 2009)(386) 3. Psyllium seed is better (in efficacy) than placebo for acute bronchitis (Kemmerich, 2007)(385) 4. Psyllium seed can reduce cholesterol on men and women with low-fat diet and hypercholesterolemia (Anderson, 2007)(384)
Purple Coneflower Herb (Echinaceae purpureae herba) 01/2008:1823Dried, whole or cut flowering aerial parts of Echinacea purpurea (L.) Moench.minimum 0.1 per cent for the sum of caftaric acid (C13H12O9 ; Mr 312.2) and cichoric acid (C22H18O12 ; Mr 474.3) (dried drug).Traditional herbal medicinal product for
treatment of small superficial wounds.
The product is a traditional herbal medicinal product for use in the specified indication
exclusively based upon long-standing use.
Herbal medicinal product for the short-term prevention and treatment of common cold.Herba Echinaceae Purpureae is administered orally in supportive therapy for colds and infections of the respiratory and urinary tract. Beneficial effects in the treatment of these infections are generally thought to be brought about by stimulation of the immune response. External uses include promotion of wound healing and treatment of inflammatory skin conditionsOther medical uses claimed for Herba Echinaceae Purpureae include treatment of yeast infections, side-effects of radiation therapy, rheumatoid arthritis, blood poisoning, and food poisoning1. Purple coneflower and its effect on the pharmacokinetics of docetaxel
(Goey, 2013)(389) 2. Discussion about if purple coneflower does enhance VO2max on distance runners (Baumann, 2014)(388) 3. Purple coneflower and prevating an treating common cold(Karsch-Völk, 2014)(391) 4. Evaluation if purple coneflower is right for common cold treatment (Shah, 2007)(392) 5. Purple coneflower and effect on immunological reactivity in chronic obstructive pulmonary disease exacerbationc (Il'nyts'kyĭ,--)(390)
Purple Coneflower Root (Echinaceae purpureae radix) 01/2008:1824Dried, whole or cut underground parts of Echinacea purpurea (L.) Moench.minimum 0.5 per cent for the sum of caftaric acid (C13H12O9 ; Mr 312.2) and cichoric acid (C22H18O12 ; Mr 474.3) (dried drug).Traditional herbal medicinal product for supportive
treatment of common cold. The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Pygeum Africanum Bark (Pruni africanae cortex) 01/2015:1886Whole or fragmented, dried bark of the stems and branches of Prunus africana (Hook.f.) Kalkman (syn. Pygeum africanum Hook.f.).Treatment of lower urinary tract symptoms of benign prostatic hyperplasia (BPH) stages I and II, as defined by Alken (e.g. nocturia, polyuria and urinary retention), in cases where diagnosis of prostate cancer is negativeAs a purgative, for the treatment of stomach and intercostal pain1. Pygeum africanum and solution for benign prostatic hyperplasia (Keehn, 2016)(395) 2. Acceptability for pygeum africanum for treat benign prostatic hyperplasia (Breza, 1998)(393) 3. Study of pygeum africanum as benign prostatic hyperplasia treatment on patients with dose of one or twice a day (Chatelain, 1999)(394)
Quillaia Bark (Quillajae cortex) 04/2013:1843Whole or fragmented, dried bark, with the cork and underlying parenchyma removed, of Quillaja saponaria Molina s.l.minimum 6.5 per cent of triterpene glycosides, expressed as quillaia saponin III (C104H168O55 ; Mr 2298) (dried drug).1. Quillaia property for Hypocholesterolemia (Kim, 2003)(396) 2. Quillia effect on dietary administration on colour, oxidative stability and volatile profile of muscle longissimus dorsi of Barbarine lamb (Nasri, 2012) (397)
Red Poppy Petals (Papaveris rhoeados flos) 01/2011:1881Dried, whole or fragmented petals of Papaver rhoeas L.1. Study of urinary concentration after herbal teas administration (including red poppy petals) (Van Thuyne, 2003)(398)(399)
Restharrow root (Ononidis radix) 07/2014:1879Whole or cut, dried root of Ononis spinosa L.Traditional herbal medicinal product used to
increase the amount of urine to achieve flushing
of the urinary tract as an adjuvant in minor
urinary complaints.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Irrigation of the urinary tract, especially in cases of inflammation and renal gravel, and as an adjuvant in treatment of bacterial infections of the urinary tract [12, 18-21].
Rhatany Root (Rhtanhiae radix) 01/2015:0289Dried, usually fragmented, underground organs of Krameria triandra Ruiz et Pav., known as Peruvian rhatanyminimum 5.0 per cent of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1) (dried drug).Minor inflammations of the mouth and throat such as stomatitis, gingivitis and pharyngitis [7-11]. These indications are pharmacologically plausible and based on long-term use and experience.
Rhatany tincture (Ratanhiae tinctura) 01/2015:1888Tincture produced from Rhatany root (0289)minimum 1.0 per cent m/m of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1).
Rhubarb (Rhei radix) 01/2008:0291Rhubarb consists of the whole or cut, dried underground parts
of Rheum palmatum L. or of Rheum officinale Baillon or of hybrids of these two species or of a mixture.
not less than 2.2 per cent of hydroxyanthracene derivatives, expressed as rhein (C15H8O6, Mr 284.2), calculated with reference to the dried drug.Herbal medicinal product for short-term use in
cases of occasional constipation.
Short-term treatment of occasional constipationTo treat hypotension, increase peripheral vasodilation, and inhibit blood coagulation1. Rhubar and its effect on primary dysmenorrhoea (Rehman, 2015) 2. Rhubarb subministartion in patients with systematic inflammation reaction syndrome/sepsis (Zhang, 2015)(400) 3. Rhubarb + early enteral nutrition for acute pancreatitis (Wan, 2014)(402) 4. Rhubarb for acute ischemic stroke (Lu, 2014)(404) 5. Treatment for acute paraquat poisoning, rhubarb is teh main substance (Wang, 2015)(401)
Ribwort Plantain (Plantaginis lanceolatae folium) 01/2012:1884Whole or fragmented, dried leaf and scape of Plantago lanceolata L. s.l.minimum 1.5 per cent of total ortho- dihydroxycinnamic acid derivatives expressed as acteoside (C29H36O15 ; Mr 624.6) (dried drug).Traditional herbal medicinal product as a
demulcent for the symptomatic treatment of oral
or pharyngeal irritations and associated dry
cough.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use
Catarrh of ythe respiratory tract [Blaschek 2007, Kraft 1996, Kraft 1996, Kraft 1998, Schilcher 2007, Willuhn 2002]. Temporary, mild inflammatory conditions of the oral and pharyngeal mucosa [Blaschek 2007, Schilcher 2007, Willuhn 2002]. Insects bites and wound healing [Marchesan 1998a, b; Schilcher 2007]. Efficacy in these latter indications is plausible on the basis of human experience and long-standing use.
Rose flower (Rosae flos)Indication 1)
Traditional herbal medicinal product used for mild
inflammations of the oral and pharyngeal mucosa. Indication 2)
Traditional herbal medicinal product used for relief
of minor skin inflammation.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Roselle (Hibisci sabdariffae flos) 01/2013:1623Whole or cut dried calyces and epicalyces of Hibiscus sabdariffa L. collected during fruiting.minimum 13.5 per cent of acids, expressed as citric acid (C6H8O7 ; Mr 192.1) (dried drug).1. To prevent patients with metabolic syndrome, Roselle (Gurrola-Díaz, 2010)(407) 2. Roselle and its effect on arterial hypertension (Serban, 2015)(405) 3. Roselle extract can modulate the production of monocyte chemoattractant protein-1 in humans (Beltrán-Debón, 2010)(408) 4. Roselle and its effect as a moderate hypertension substance (Herrera-Arellano, 2004)(406)
Rosemary Leaf (Rosmarini folium) 01/2013:1560Whole, dried leaf of Rosmarinus officinalis L.– minimum 12 mL/kg of essential oil (anhydrous drug);
– minimum 3 per cent of total hydroxycinnamic derivatives, expressed as rosmarinic acid (C18H16O8 ; Mr 360.3) (anhydrous drug).
Adolescents, adults
ORAL USE
Indication 1)
Traditional herbal medicinal product for
symptomatic relief of dyspepsia and mild
spasmodic disorders of the gastrointestinal tract.
USE AS BATH ADDITIVE
Indication 2)
Traditional herbal medicinal product as an
adjuvant in the relief of minor muscular and
articular pain and in minor peripheral circulatory
disorders.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Orally as a carminative and spasmolytic to treat dyspepsia. Externally
for supportive therapy of rheumatism and circulatory disorders
Orally as a cholagogue, diaphoretic, diuretic, emmenagogue and as a tonic. Also used in the management of headache, menstrual disorders,
nervous menstrual complaints, tiredness and defective memory.
Used externally for treatment of spraining and bruising
1. A full review of Reosemary leaf (Begum, --)(412) 2. Rosemary leaf as a supplement on goat's production and metabolic statue (Smeti, 2015)(409) 3. Rsoemary effects on on cognitive function in an elderly population (Pengelly, 2012)(410) 4. Canephron N combination can have diabetic nephropathy effect in patients with diabtes mellitus (Martynyuk, 2014)(411)
Rosemary Oil (Rosmarini aetheroleum) 01/2008:1846Essential oil obtained by steam distillation from the flowering
aerial parts of Rosmarinus officinalis L.
ORAL USE
Indication 1)
Traditional herbal medicinal product for
symptomatic relief of dyspepsia and mild
spasmodic disorders of the gastrointestinal tract. CUTANEOUS USE & USE AS BATH ADDITIVE
Indication 2)
Traditional herbal medicinal product as an
adjuvant in the relief of minor muscular and
articular pain and in minor peripheral circulatory
disorders.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Used orally for the treatment of dyspeptic complaints, and in external applications
for supportive management of rheumatic complaints and circulatory
disorders. Although one pilot study has indicated that the crude drug may enhance cognition, further data from randomized
controlled clinical trials are required before any therapeutic recommendations
can be made.
Used as a cholagogue, diaphoretic, digestant, diuretic, emmenagogue,
laxative and a tonic. Also used in the management of headache,
menstrual disorders, nervous menstrual complaints, tiredness, defective
memory, sprains and bruises
Round Amomum Fruit (Amomi fructus rotundus) 04/2014:2555Dried, whole, peeled or unpeeled ripe fruit of Amomum krervanh Pierre ex Gagnep. or Amomum compactum Sol. ex Maton.– essential oil: minimum 50 mL/kg for A. krervanh (anhydrous drug) and minimum 40 mL/kg for A. compactum (anhydrous drug);
– 1,8-cineole (C10H18O ; Mr 154.3) : minimum 65.0 per cent of the essential oil.
Safflower Flower (Carthami flos) 07/2014:2386Dried flower of Carthamus tinctorius L.minimum 1.0 per cent of total flavonoids, expressed
as hyperoside (C21H20O12 ; Mr 464.4) (dried drug).
NoneTreatment of amenorrhoea, dysmenorrhoea and wounds or sores with
pain and swelling, and prevention of atherosclerosis. As an antipyretic, antidiarrhoeal, contraceptive, diaphoretic, emmenagogue,
expectorant, laxative, sedative and stimulant. Treatment
of bronchitis, boils, haemorrhoids, respiratory tract infections, ringworm
and scabies
1. Study of allergic schok caused by safflower injection (Sun, 2013)(414) 2. Safflower seed as supplementation for gestatingh ewes (Encinias, 2004)(415) 3. Hydroxysafflor yelloe A, pharmacokinetic properties (Yang, 2009)(413)
Sage Leaf (Salvia officinalis) 01/2015:1370Whole or cut, dried leaves of Salvia officinalis L.(ESSENTIAL OIL CONTENT): – for the whole drug, minimum 12 mL/kg (anhydrous drug);
– for the cut drug, minimum 10 mL/kg (anhydrous drug).
a) Traditional herbal medicinal product for
symptomatic treatment of mild dyspeptic,
complaints such as heartburn and bloating.
b) Traditional herbal medicinal product for relief
of excessive sweating.
c) Traditional herbal medicinal product for the
symptomatic treatment of inflammations in
the mouth or the throat.
d) Traditional herbal medicinal product for relief
of minor skin inflammations.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
1. Sage leaf oil as supplement on egg production on quail (Çabuk, 2014)(419) 2. Cholinesterase inhibiting sage on mood, anxiety and so on (Kennedy, 2006)(418) 3. Sage leaf, full review (Mahendran, 2016)(416) 4. Sage leaf antihyperlipidemic effect in patients with hyperlipidemia (Kianbakht, 2011) (417)
Sage Leaf, Three-Lobed (Salviae trilobae folium) 07/2014:1561Whole or cut, dried leaves of Salvia fructicosa Mill. (syn. Salvia triloba L. fil).(ESSENTIAL OIL CONTENT) : – for the whole drug, minimum 18 mL/kg (anhydrous drug);
– for the cut drug, minimum 12 mL/kg (anhydrous drug).
Inflammations and infections of the mouth and throat such as stomatitis, gingivitis and pharyngitis [Stahl-Biskup 2008, Benedum 2006]; digestive disorders such as dyspepsia [Benedum 2006]. Efficacy for these indications is plausible on the basis of human experience and long-standing use.
Sage tincture (Salviae tinctura) 01/2008:1889Tincture produced from Sage leaf (Salvia officinalis) (1370).minimum 0.1 per cent m/m of essential oil.
Salvia Miltiorrhiza Root & Rhizome (Salviae miltiorrhizae radix et rhizoma) 04/2013:2663Dried, whole or fragmented rhizome and root of Salvia miltiorrhiza Bunge, collected in spring or autumn.– salvianolic acid B (C36H30O16 ; Mr 719) : minimum 3.0 per
cent (dried drug);
– tanshinone IIA (C19H18O3 ; Mr 294.3) : minimum 0.12 per cent (dried drug).
1. Salvia miltiorrhiza and pharmacotherapy for psoriasis vulgaris (Zhang, 2014)(420) 2. Clinical observation of danhong Injection (Sun, 2009)(422) 3. Chinese herbal medicine for diabetic retinopathy effectiveness and safety (Lian, 2015)(425) 4. Proof that Salvia miltiorrhiza has no effect on Cardiovascular risk factors (Van Poppel, 2015)(421) 5. Study of salvia miltiorrhiza injection on pulmonary heart disease (Liu, 2014)(424) 6. Compound Danshen (Salvia miltiorrhiza) dripping pill for coronary heart disease (Lou, 2015)(423)
Sandy everlasting (Helichrysi flos)1. Sandy everlasting as dietary supplements for dyasmenorrhoea (Pattanittum, 2016)(426) 2. Sandy everlasting, full review (Antune Viegas, 2014) (427)
Sanguisorba Root (Sanguisorbae radix) 04/2008:2385Whole or fragmented, dried undergorund parts of Sanguisorba officinalis L. Without rootlets. minimum 5.0 per cent of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1) (dried drug).1. Sanguisorba root extract can be a cosmeceutical ingredient (Kim, 2008)(428) 2. Sanguisorba root review (Guarrera, 2013)(429)
Saw palmetto extract (Sabalis serrulatae extractum) 01/2014:2579Extract produced from Saw palmetto fruit (1848).– total fatty acids: minimum 80.0 per cent (anhydrous ex) ;
– lauric acid (C12H24O2 ; Mr 200.3) : minimum 23.0 per cent (anhydrous ex);
– total sterols, expressed as β-sitosterol (C29H50O ; Mr 414.7) : minimum 0.20 per cent (anhydrous ex);
– β-sitosterol (C29H50O ; Mr 414.7) : minimum 0.10 per cent (anhydrous ex).
Saw Palmetto Fruit (Sabalis serrulatae fructus) 07/2012:1848Dried ripe fruit of Serenoa repens (W. Bartram) Small (syn. Sabal serrulata (Michaux) T. Nuttal ex Schultes & Schultes).minimum 11.0 per cent of total fatty acids (dried drug).Traditional medicinal product for the relief of lower
urinary tract symptoms related to benign prostatic
hyperplasia, after serious conditions have been
excluded by a doctor.
The product is a traditional herbal medicinal product for use in the specified indication
exclusively based upon long-standing use.
Herbal medicinal product for the symptomatic treatment of benign prostatic hyperplasiaTreatment of lower urinary tract symptoms (nocturia, polyuria, urinary retention) secondary to BPH stages I and II, as defined by Alken, in cases where diagnosis of prostate cancer is negative.As a diuretic and to treat an enlarged prostate. As an aphrodisiac, a sedative and a nutritional tonic, as well as for the treatment of bronchitis, cystitis, dysmenorrhoea, sore throat and the common cold.1. Saw palmetto extract as a lower urinary tract symptoms treatment (Barry, 2011)(434) 2. Saw palmetto for benign prostatic hyperplasia treatment (Wilt, 1998)(430) 3. Discussion between the risk and benefits of common herbal therapies uses (Ernst, 2002)(432) 4. Saw palmetto clinical trial and study on double-blind prticipants (Kaplan, 2015)(431) 5. Saw palmetto extract associated with Unidrox® , as a short-lasting antibiotic therapy (Busetto, 2014) (433)
Schisandra Fruit (Schisandrae chinensis fructus) 07/2016:2428Whole, dried or steamed and dried, ripe fruit of Schisandra chinensis (Turcz.) Baill.minimum 0.40 per cent of schisandrin (C24H32O7 ; Mr 432.5) (dried drug).None. Although some clinical evidence supports the use of Fructus
Schisandrae for the treatment of psychosis, gastritis, hepatitis and fatigue
(16, 17), data from controlled clinical trials are lacking. Treatment of chronic cough and asthma, diabetes, urinary tract disorders.
As a general tonic for treating fatigue associated with illness.
As an astringent, antitussive, antidiarrhoeal, expectorant and sedative1. Study of single dose of ADAPT-232 on cognitive functions (Aslanyan, 2910)(438) 2.Schisandra fruit extract and its lignans against cardiovascular disease (Chun, 2014)(436) 3.Schisandra fruit and sesamin can improve liver function (Chiu, 2013)(437) 4. Schisandra chinensis fruit modulates the gut microbiota composition in association with metabolic markers in obese women (Song, 2015)(435)
Senega Root (Polygalae radix) 01/2008:0202Dried and usually fragmented root and root crown of Polygala senega L. or of certain other closely related species or of a mixture of these Polygala species.NoneAs an expectorant for symptomatic treatment of coughs due to bronchitis, emphysema and catarrh of the upper respiratory tract. Treatment of amenorrhoea, asthma, constipation, rheumatism and snake bites1. BT-11 is effective for enhancing cognitive functions in the elderly humans (Shin, 2009)(439) 2. Effects of BT-11 on memory in healthy humans (Lee, 2009)(440)
Senna Leaf (Sennae folium) 01/2015:0206Dried leaflets of Cassia senna L. (syn. Cassia acutifolia Delile), known as Alexandrian or Khartoum senna, or Cassia angustifolia Vahl, known as Tinnevelly senna, or a mixture of the 2 species.minimum 2.5 per cent of hydroxyanthracene glycosides, expressed as sennoside B (C42H38O20 ; Mr 863) (dried drug).NoneHerbal medicinal product for short-term use in
cases of occasional constipation.
Short-term use in occasional constipationAs an expectorant, a wound dressing, an antidysenteric, and a carminative agent; and for the treatment of gonorrhoea, skin diseases, dyspepsia, fever, and haemorrhoidsFor short-term use in cases of occasional constipation [7-21].1. Senna leaf is illegal in some heakth food products from National Institute of Health Sciences in Japan(Goda, 2014)(441)
Senna leaf dry extract, standardised (Senna folii extractum siccum normatum) 07/2015:1261Standardised dry extract produced from Senna leaf (0206). 5.5 per cent to 8.0 per cent of hydroxyanthracene glycosides, expressed as sennoside B (C42H38O20 ; Mr 863) (dried extract). The measured content does not deviate from the value stated on the label by more than ± 10 per cent.
Senna Pods, Alexandrian (Sennae fructus acutifoliae) 01/2015:0207Dried fruit of Cassia senna L. (syn. Cassia acutifolia Delile).minimum 3.4 per cent of hydroxyanthracene glycosides, expressed as sennoside B (C42H38O20 ; Mr 863) (dried drug)Well-established use (not specified)Short-term use in occasional constipationAs an expectorant, a wound dressing, an antidysenteric, and a carminative agent; and for the treatment of gonorrhoea, skin diseases, dyspepsia, fever, and haemorrhoids
Senna Pods, Tinnevelly (Sennae fructus angustifoliae) 01/2015:0208Dried fruit of Cassia angustifolia Vahl.minimum 2.2 per cent of hydroxyanthracene glycosides, expressed as sennoside B (C42H38O20 ; Mr 863) (dried drug).NoneHerbal medicinal product for short-term use in
cases of occasional constipation.
Short-term use in occasional constipationAs an expectorant, a wound dressing, an antidysenteric, and a carminative agent; and for the treatment of gonorrhoea, skin diseases, dyspepsia, fever, and haemorrhoids
Shepherds Purse (Bursae pastoris herba)Traditional herbal medicinal product for the reduction of heavy menstrual bleeding in women with regular menstrual cycles, after serious conditions have been excluded by a medical
doctor.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Silver lime flower (Tiliae tomentosae flos)
Sophora Flower (Sophorae japonicae flos) 01/2015:2639Dried, opened flower of Styphnolobium japonicum (L.) Schott
(syn. Sophora japonica L.).
– minimum 8.0 per cent of total flavonoids, expressed as rutin (C27H30O16 ; Mr 611) (dried drug) ;
– minimum 6.0 per cent of rutin (C27H30O16 ; Mr 611) (dried drug).
1. Sophora flower, general information (uses, phytochemistry...) (He, 2016)(444) 2. Clinical trial about Sophora flower formula in patients with symptomatic haemorrhoids (Man, 2013)(443) 3. Study of flavonoid luteolin and its effect on behavior in children aith autism apectrum disorders (Taliou, 2013) (442)
Sophora Flower-Bud (Sophorae japonicae flos immaturus) 01/2015:2427Whole, dried flower bud of Styphnolobium japonicum (L.) Schott (syn. Sophora japonica L.).– minimum 20.0 per cent of total flavonoids, expressed as
rutin (C27H30O16 ; Mr 611) (dried drug) ;
– minimum 15.0 per cent of rutin (C27H30O16 ; Mr 611) (dried
drug).
Soya-bean lecithin (Lecithinum ex soya)1. Positive effects of lecithin-derived phosphatidylserine on memory, cognition, daily functioning, and mood in elderly patients with alzehimer (Moré, 2014)(445) 2. Association of soybean-based extenders with field fertility of stored ram (Ovis aries) semen (Khalifa, 2013)(446)
Soya-bean oil, refined (Soiae oleum raffinatum)
Spanish sage oil (Slaviae lavandulifoliae aetheroleum) 07/2008:1849Essential oil obtained by steam distillation from the aerial
parts of Salvia lavandulifolia Vahl, collected at the flowering stage.
Spike lavender oil (Spicae aetheroleum) 07/2009:2419Essential oil obtained by steam distillation of the flowering
tops of Lavandula latifolia Medik.
St. John's Wort (Hyperici herba) 01/2017:1438Whole or fragmented, dried flowering tops of Hypericum
perforatum L., harvested during flowering time.
minimum 0.08 per cent of total hypericins, expressed
as hypericin (C30H16O8 ; Mr 504.4) (dried drug).
Indication 1: Herbal substance, herbal preparations A, C, D, E,
F, G, H, I, J:
Traditional herbal medicinal product for the relief
of temporary mental exhaustion.
Indication 2: Herbal preparations B, D, E, I:
Traditional herbal medicinal product for the
symptomatic treatment of minor inflammations of
the skin (such as sunburn) and as an aid in healing
of minor wounds.
Indication 3: Herbal preparation I:
Traditional herbal medicinal product for the
symptomatic relief of mild gastrointestinal
discomfort.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
Indication 1
Herbal preparations A, B:
Herbal medicinal product for the treatment of
mild to moderate depressive episodes (according
to ICD-10). Indication 2
Herbal preparation C:
Herbal medicinal product for the short term
treatment of symptoms in mild depressive
disorders.
Symptomatic treatment of mild and moderate depressive episodes (classified as F32.0 and F32.1, respectively, in the International statistical classification of diseases and related health problems, Tenth revision (ICD-10)Externally for the treatment of minor cuts, burns and skin ulcers. Topically for viral infections. As an antiphlogistic agent in the treatment of inflammation of the bronchi and urogenital tract; treatment of biliary disorders, bladder irritation, the common cold, diabetes mellitus, dyspepsia, haemorrhoids, neuralgia, migraine headaches, sciatica and ulcers. Also used as a diuretic, an emmenagogue and an antimalarial agent1. Nonresponse of Placebo Compared With Antidepressants or St John’s Wort in Major Depressive Disorder (Sarris, 2013)(447) 2. St john's wort as treatment for depression (Linde, 2005)(449) 3.Hypericum perforatum extract in treatment of mild to moderate depression (Laakmann, 2002)(450) 4. St john's wort preparations for menopause (Liu, 2014)(448) 5. Analysis of symptoms during St john0s wort antidepressant treatment (Kasper, 2002) (451)
St. John wort dry extract, quantified (Hyperici herbae extractum siccum quantificatum) 01/2013:1874Quantified dry extract obtained from St. John’s wort (1438).– total hypericins, expressed as hypericin (C30H16O8 ; Mr 504.4) : 0.10 per cent to 0.30 per cent (anhydrous ex.)– flavonoids, expressed as rutoside (C27H30O16 ; Mr 610.5) : minimum 6.0 per cent (anhydrous ex.);
– hyperforin (C35H52O4 ; Mr 536.8) : maximum 6.0 per cent (anhydrous extr) and not more than the content stated on the label.
Star Anise (Anisi stellati fructus) 01/2008:1153Dried composite fruit of Illicium verum Hook.f.– minimum 70 mL/kg of essential oil (anhydrous drug),
– minimum 86.0 per cent of trans-anethole in the essential oil.
1. Effects of a phytogenic feed additive on growth performance and ileal nutrient digestibility in broiler chickens (Amad, 2011)(452) 2. Different techniques thorugh the years (Martínez, 2015)(453)
Star anise oil (Anisi stellati aetheroleum) 01/2008:2108Essential oil obtained by steam distillation from the dry ripe
fruits of Illicium verum Hook.f.
Indication 1)
Traditional herbal medicinal product for
symptomatic treatment of mild, spasmodic gastrointestinal
complaints including bloating and
flatulence. Indication 2) Traditional herbal medicinal product used as an
expectorant in cough associated with cold.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Stramonium Leaf (Stramonii folium) 01/2012:0246Dried leaf or dried leaf and flowering, and occasionally fruit-bearing, tops of Datura stramonium L. and its varieties.minimum 0.25 per cent of total alkaloids, expressed as hyoscyamine (C17H23NO3 ; Mr 289.4) (dried drug). The alkaloids consist mainly of hyoscyamine with varying proportions of hyoscine (scopolamine).
Stramonium, Prepared (Stramonii pulvis normatus) 01/2008:0247Stramonium leaf powder (180) (2.9.12) adjusted, if necessary, by the addition of powdered lactose or stramonium leaf of lower content of total alkaloids.0.23 per cent to 0.27 per cent of total alkaloids, expressed as hyoscyamine (C17H23NO3 ; Mr 289.4) (dried drug).
Sweet orange oil (Aurantii dulcis aetheroleum) 01/2008:1811Essential oil obtained without heating, by suitable mechanical treatment from the fresh peel of the fruit of Citrus sinensis (L.) Osbeck (Citrus aurantium L. var. dulcis L.). A suitable antioxidant may be added.
Sweet orange oil (Aurantii dulcis aetheroleum) 01/2008:1811Essential oil obtained without heating, by suitable mechanical treatment from the fresh peel of the fruit of Citrus sinensis (L.) Osbeck (Citrus aurantium L. var. dulcis L.). A suitable antioxidant may be added.
Tea-tree oil (Melaleucae aetheroleum) 01/2008:1837Essential oil obtained by steam distillation from the foliage and terminal branchlets of Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca.Indication 1)
Traditional herbal medicinal product for treatment
of small superficial wounds and insect bites. Indication 2)
Traditional herbal medicinal product for treatment
of small boils (furuncles and mild acne). Indication 3)
Traditional herbal medicinal product for the relief
of itching and irritation in cases of mild athlete´s
foot. Indication 4)
Traditional herbal medicinal product for
symptomatic treatment of minor inflammation of
the oral mucosa.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use
Topical application for symptomatic treatment of common skin disorders such as acne, tinea pedis, bromidrosis, furunculosis, and mycotic onychia (onychomycosis), and of vaginitis due to Trichomonas vaginalis or Candida albicans, cystitis and cervicitisAs an antiseptic and disinfectant for the treatment of wounds. Symptomatic treatment of burns, colitis, coughs and colds, gingivitis, impetigo, nasopharyngitis, psoriasis, sinus congestion, stomatitis and tonsillitis1. Tea tree oil' activity as antifungal, against Trichophyton equinum (Pisseri, 2009)(454)
Thomson Kudzuvine Root (Puerariae thomsonii radix) 01/2012:2483Whole or fragmented, dried root of Pueraria thomsonii Benth., with the outer bark removed.minimum 0.4 per cent of total isoflavonoids, expressed as puerarin (C12H20O9 ; Mr 416.4) (dried drug), of which minimum 55 per cent consists of puerarin.1. Thomson kudzuvine root general information, chemistry, pharmacology etc. (Zhang, 2013)(455) 2. Thomson kudzuvine root extract can reduce body mass index via a decrease in the visceral fat area in obese humans (Kamiya, 2012)(456)
Thyme (Thymi herba) 07/2014:0865Whole leaves and flowers separated from the previously dried stems of Thymus vulgaris L. or Thymus zygis L. or a mixture of both species– essential oil: minimum 12 mL/kg (anhydrous drug);
– sum of the contents of thymol and carvacrol (both C10H14O; Mr 150.2): minimum 40 per cent in the essential oil.
Traditional herbal medicinal product used in
productive cough associated with cold.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Dried herb for infusion, extract, and tinctureThyme extract has been used orally to treat dyspepsia and other gastrointestinal disturbances; coughs due to colds, bronchitis and pertussis; and laryngitis and tonsillitis (as a gargle). Topical applications of thyme extract have been used in the treatment of minor wounds, the common cold, disorders of the oral cavity, and as an antibacterial agent in oral hygiene. Both the essential oil and thymol are ingredients of a number of proprietary drugs including antiseptic and healing ointments, syrups for the treatment of respiratory disorders, and preparations for inhalation. Another species in the genus, T. serpyllum L., is used for the same indications1. Thyme effect of feeding goats with distilled amd non-distilled thyme leaves (Boutoial, 2013)(459) 2. Thyme extract and its effects on male broiler performance (Alipour, 2015)(460) 3. Thyme honel nasal spray on chronic rhinosinusitis effect (Hashemian, 2015)(458) 4. Systemic availability and pharmacokinetics of Thyme (Kohlert, 2002)(457) 5. Thyme herb and primrose root in adults suffering from acute bronchitis with productive cough efficacy and tolerability (Kemmerich, 2007) (385)
Thyme / Primula root (Thymi herba / Primulae radix)
Thyme oil, thymol type (thymi typo thymolo aetheroleum) 01/2012:1374Essential oil obtained by steam distillation from the fresh flowering aerial parts of Thymus vulgaris L., T. zygis L. or a mixture of both species.
Indication 1)
Traditional herbal medicinal product used as an
expectorant in cough associated with cold.
Indication 2)
Traditional herbal medicinal product for the relief
of symptoms in coughs and colds.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Tolu balsam (Blasamum tolutanum) 01/2008:1596Oleo-resin obtained from the trunk of Myroxylon balsamum (L.) Harms var. balsamum.25.0 per cent to 50.0 per cent of free or combined acids, expressed as cinnamic acid (C9H8O2 ; Mr 148.2) (dried drug).
Tormentil (Tormentillae rhizoma) 07/2010:1478Whole or cut, dried rhizome, freed from the roots, of Potentilla erecta (L..) Raeusch. (P. Tormentilla Stokes) .minimum 7 per cent of tannins, expressed as pyrogallol (C6 H6O3 ; Mr 126.1) (dried drug).Indication 1)
Traditional herbal medicinal product for
symptomatic treatment of mild diarrhoea.
Indication 2)
Traditional herbal medicinal product for the
symptomatic treatment of minor inflammations of
the oral mucosa.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Non-specific, acute diarrhoea [Braun 1953, Hoffmann 1954, Horz 1994, Schulz 1999, Frohne 2002, Fintelmann 2002, Subbotina 2003, Schilcher 2007]. Adjuvant treatment of acute and subacute enteritis and colitis [Fintelmann 2002, Huber 2007, Moss 2007, Schilcher 2007]. Slight irritations f the mucosa of mouth and throat [Braun 1953, Hpffmann 1954, 1955; Horz 1994, Volodina 1997, Fintelmann 2002, Frohne 2002, Schilcher 2007]. Efficacy in these indications is plausible on the basis of human experience and long-distance use.1. Tormentil as inflammatory bowel disease (Triantafillidis, --)(461) 2. Study of tormentil root extract administration on rotavirus diarrhea in children (Subbotina, 2003)(462) 3. Tormentil for active ulcerative colitis (Huber, 2007)(463)
Tormentil tincture (Tormentillae tincture)01/2008:1895Tincture produced from Tormentil (1478).minimum 1.5 per cent m/m of tannins, expressed as pyrogallol (C6H6O3 ; Mr 126.1).
Tragacanth (Tragacantha) 01/2009:0532Air-hardened, gummy exudate, flowing naturally or obtained by incision from the trunk and branches of Astragalus gummifer Labill. and certain other species of Astragalus from western Asia.1. Study of immune reactivities against gums (Vojdani, 2015)(464) 2. Denture adhesives in prosthodontics (Kumar, 2015)(465)
Turmeric Rhizome (Curcumae longae rhizoma) 01/2015:2543Traditional herbal medicinal product used to
increase bile flow for the relief of symptoms of
indigestion (such as sensation of fullness,
flatulence, and slow digestion).
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
The principal use of Rhizoma Curcumae Longae is for the treatment of acid, flatulent, or atonic dyspepsiaTreatment of peptic ulcers, and pain and inflammation due to rheumatoid arthritis and of amenorrhoea, dysmenorrhoea, diarrhoea, epilepsy, pain, and skin diseases. The treatment of asthma, boils, bruises, coughs, dizziness, epilepsy, haemorrhages, insect bites, jaundice, ringworm, urinary calculi, and slow lactation1. Effect of Curcuma longa in human liver microsomoes and healthy human subjects (Al-Jenoobi, 2015)(468) 2. Curcumin (a pleiotropic signalling in the treatment of glioblastoma) (Luthra, 2016) (469)
Turmeric, Javanese (Curcumae xanthorrhizae rhizoma) 01/2015:1441Dried rhizome, cut in slices, of Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich).– essential oil: minimum 50 mL/kg (anhydrous drug);
– dicinnamoyl methane derivatives, expressed as curcumin (C21H20O6 ; Mr 368.4) : minimum 1.0 per cent (anhydrous drug).
Traditional herbal medicinal product used for symptomatic treatment of digestive disturbances, such as feelings of fullness, slow digestion and flatulence. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.1. Zingiberaceae extracts for pain (Lakhan, 2015)(466) 2. Effect of Curcuma longa in human liver microsomoes and healthy human subjects (Al-Jenoobi, 2015)(468) 3. Study of P54FP for the treatment of dogs with osteoarthritis (Innes, 2003)(467)
Turpentine oil (Terebinthinae aetheroleum) 07/2014:1627Essential oil obtained by steam distillation, followed by rectification at a temperature below 180 °C, from the oleoresin obtained by tapping Pinus pinaster Aiton and/or Pinus massoniana D.Don. A suitable antioxidant may be added.
Tyme1. Common characteristics between concentrations of microbiological agents in the air and occurrence of work-related symptoms in exposed persons (Mackiewicz, 2015)(470)
Uncaria stem with hooks (Uncariae rhynchophyllae ramulus cum uncis) 01/2017:2729Fragments of dried branch or stem of Uncaria rhynchophylla (Miq.) Miq. ex Havil., each bearing paired hooks.minimum 0.2 per cent of total alkaloids, expressed as isorhynchophylline (C22H28N2O4 ; Mr 384.5) (dried drug).Used orally to treat eclampsia, headache, dizziness, high fevers and hypertension. Considering the serious nature of these diseases, the usefulness
of the crude drug needs to be confirmed by controlled clinical studies.
Used as a carminative, diuretic, and a muscle relaxant. Also used to treat
cardiovascular disease, colic, convulsions, stroke and vertigo
1. Unicaria stem with Hooks, information about rhynchophylla based on chemical stability (Hao, 2014)(471)
Valerian dry aqueous extract (Valerianae extractum aquosum siccum) 07/2010:2400Extract produced from Valerian root (0453).minimum 0.02 per cent of sesquiterpenic acids, expressed as valerenic acid (C15H22O2 ; Mr 234.3) (dried extract).
Valerian dry hydroalcoholic extract (Valerianae extractum hydroalcoholieum siccum) 07/2014:1898Extract produced from Valerian root (0453).minimum 0.25 per cent m/m of sesquiterpenic acids, expressed as valerenic acid (C15H22O2 ; Mr 234.3) (anhydrous extract).
Valerian essential oil (Valerianae aetheroleum)
Valerian Root (Valerianae radix) 07/2015:0453Dried, whole or fragmented underground parts of Valeriana officinalis L. s.l., including the rhizome surrounded by the roots and stolons.– essential oil: minimum 4 mL/kg (dried drug);
– sesquiterpenic acids: minimum 0.17 per cent m/m, expressed as valerenic acid (C15H22O2 ; Mr 234.3) (dried drug) ;
Traditional herbal medicinal product for relief of
mild symptoms of mental stress and to aid sleep.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based on long-standing use.
Herbal medicinal product for the relief of mild
nervous tension and sleep disorders.
As a mild sedative and sleep-promoting agent. The drug is often used as a milder alternative or a possible substitute for stronger synthetic sedatives, such as the benzodiazepines, in the treatment of states of nervous excitation and anxiety-induced sleep disturbancesAs a digestive aid, and an adjuvant in spasmolytic states of smooth muscle and gastrointestinal pains of nervous origin. When associated with papaverine, belladonna, and other spasmolytics, Radix Valerianae has been shown to be useful as an adjuvant in spastic states of smooth muscle such as spastic colitis. To treat epilepsy, gum sores, headaches, nausea, sluggish liver, urinary tract disorders, vaginal yeast infections, and throat inflammations; and as an emmenagogue, antiperspirant, antidote to poisons, diuretic, anodyne, and a decoction for coldsVALERIAN 1. Valerian and lemon balm effectiveness in the treatment of restlessness and dyssomnia in children (Müller, 2006)(472) VALERIAN ROOT 1. Valerian for sleep, review and meta-analysis (Bent, 2006)(476) 2. Valerian root extract to prevent early postoperative cognitive dysfunction after CABG surgery (Hassani, 2015)(474) 3. Valerian root as example for assessment of genetoxicity of herbal medicinal products (Kelber, 2014)(473) 4. Valerian and its effect of sleep difficulties in children with intellectual deficits (Francis, 2002) (475)
Valerian Root, Cut (Valerianae radix minutata) 07/2016:2526Dried, cut underground parts of Valeriana officinalis L. s.l., including the rhizome, roots and stolons.– essential oil: minimum 3 mL/kg (dried drug);
–sesquiterpenic acids : minimum 0.10 per cent m/m expressed
as valerenic acid (C15H22O2 ; Mr 234.3) (dried drug).
Valerian Root/Hop Strobile ( Valeriana officinalis L.,
radix and Humulus lupulus L., flos )
Indication 1)
Traditional herbal medicinal product for relief of
mild symptoms of mental stress.
Indication 2)
Traditional herbal medicinal product used to aid
sleep.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based on long-standing use.
Herbal medicinal product for the relief of sleep
disorders.
Valerian tincture (Valerianae tinctura) 07/2010:1899Tincture produced from Valerian root (0453)minimum 0.015 per cent m/m of sesquiterpenic
acids, expressed as valerenic acid (C15H22O2 ; Mr 234.3).
Verbena Herb (Verbenae Herba) 07/2012:1854Whole or fragmented, dried aerial parts of Verbena officinalis L. Collected during flowering. minimum 1.5 per cent of verbenalin (C17H24O10 ; Mr 388.4) (dried drug).1. Inhibition of non-haem iron absorption in man by polyphenolic-containing beverages (Hurrell, 1999) (478) 2. BNO-101 in the treatment of sinusitis (Melzer, 2006)(477)
Walnut leaf (Juglandis folium)Indication 1)
Traditional herbal medicinal product for the relief
of minor inflammatory conditions of the skin.
Indication 2)
Traditional herbal medicinal product used in
excessive perspiration of hands and feet.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use
1. Evaluation of topical dosage forms and its formation (Walnut leaf) (Khiljee, 2015)(479) 2. Effects of Walnut leaf extract on two types of diabetics patients (Hosseini, 2014)(480)
White Horehound (Marrubii herba) 01/2008:1835Whole or fragmented dried flowering aerial parts of Marrubium vulgare L.minimum 0.7 per cent of marrubiin (C20H28O4 ; Mr 332.4) (dried drug).Indication 1)
Traditional herbal medicinal product used as an
expectorant in cough associated with cold.
Indication 2)
Traditional herbal medicinal product used for
symptomatic treatment of mild dyspeptic
complaints such as bloating and flatulence.
Indication 3)
Traditional herbal medicinal product used in
temporary loss of appetite.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Loss of appetite; dyspeptic complaints such as bloating and flatulence (Jänicke 2003, Schilcher 2007, Seitz 2007, Blaschek 2009]. Catarrh of the upper respiratory tract [Bradley 1992, Teuscher 2004, Schilcher 2007, Seitz 2007, Blaschek 2009]. 1. White horehound and finding fallacies and paradigms (Rodríguez Villanueva, 2016)(481) 2. White horehound composition to alleviate clinical signs of respiratory dysfunction in horses with current airway obstruction (Pearson, 2007) (482)
Wild Pansy (Flowering aerial parts) (Violae herba cum flore) 01/2008:1855Dried flowering aerial parts of Viola arvensis Murray and/or Viola tricolor L.minimum 1.5 per cent of flavonoids, expressed as violanthin (C27H30O14 ; Mr 578.5) (dried drug).Traditional herbal medicinal product for
symptomatic treatment of mild seborrhoeic skin
conditions.
The product is a traditional herbal medicinal
product for use in specified indication exclusively
based upon long-standing use.
Skin disorders such as eczema, seborrhoea, impetigo and acne, as well as cradlecap and nappy-rash of infants [Bradley 2006, Rimkiene 2003, Hänsel 1994, Wichtl 2001, Van Hellemont 1988, Schilcher 2006.] In these indications, the efficacy is plausible on the basis of human experience and long-standing use.
Wild Thyme (Serpylli Herba) 07/2014:1891Whole or cut, dried, flowering aerial parts of Thymus serpyllum L. s.l.minimum 3.0 mL/kg of essential oil (dried drug).INTERNAL USE: Catarrh of the upper respiratory tract [Jänicke 2003, Schilcher 2010, Stahl-Biskup 2007, Stahl-Biskup 2009]. EXTERNAL USE: As a bath additive in the supportive treatment of acute or chronic diseases of the respiratory tract [Jänicke 2003, Stahl-Biskup 2007.] Efficacy in these indications is plausible on the basis of human experience and long-standing use.1. Wild thyme general information (Phytochemical, pharmacological study) (Jarić, 2015)(483)
Willow Bark (Salicis cortex) 01/2013:1583Whole or fragmented dried bark of young branches or whole dried pieces of current-year twigs of various species of genus Salix including S. purpurea L., S. daphnoides Vill. and S. fragilis L.minimum 1.5 per cent of total salicylic derivatives, expressed as salicin (C13H18O7 ; Mr 286.3) (dried drug).Traditional herbal medicinal product used for the
relief of:
a) minor articular pain
b) fever associated with common cold
c) headache.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
Herbal medicinal product used for the short-term
treatment of low back pain.
Used orally for the symptomatic treatment of fever and pain, and symptomatic
treatment of mild rheumatic conditions. Used orally for the treatment of the common cold
Used orally for the treatment of constipation and urinary incontinence.
Used externally for the treatment of warts.
1. Study of willow bark extract in long-term treatment of patients with reumatic pain mainly osteoarthritis or back pain (Uehleke, 2013)(484) 2. Willow bark extract for gonarthrosis and coxarthrosis (Beer, 2008)(486) 3. Willow bark for low back pain treatment (Gagnier, 2016)(485)
Willow bark dry extract (Salicis corticis extractum siccum) 04/2008:2312Dry extract produced from Willow bark (1583).minimum 5.0 per cent of total salicylic derivatives, expressed as salicin (C13H18O7 ; Mr 286.3) (dried extract).
Willow herb (Epilobii herba)Traditional herbal medicinal product for the relief
of lower urinary tract symptoms related to benign
prostatic hyperplasia after serious conditions have
been excluded by a medical doctor.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
Winter Cherry Root (Angelicae sinensis radix)None. Although Radix Angelicae Sinensis has been alleged to be useful for the treatment of menopausal symptoms, a randomized, placebo-controlled clinical trial concluded that 4.5 g of the root daily for 24 weeks did not alleviate menopausal symptoms, such as hot flushesTreatment of menstrual disorders such as irregular menstruation, amenorrhoea and dysmenorrhoea. As an analgesic for symptomatic treatment of rheumatic arthralgia, abdominal pain and in the management of postoperative pain. Treatment of constipation, anaemia, chronic hepatitis and cirrhosis of the liver. Treatment of dehydration, lumbago, abnormal menstruation, menopausal symptoms (including hot flushes), hypertonia and nervous disorders1. Winter cherry root for treatment of neurodegenerative disorders (Ven Murthy, 2010)(487) 2. Winter cherry root, as hypoglycemic, diuretic and hypocholesterolemic effects (Anadllu, 2000)(488)
Wormwood (Absinthii Herba) 04/2011:1380Basal leaves or slightly leafy, flowering tops, or mixture of these dried, whole or cut organs of Artemisia absinthium L.minimum 2 mL/kg of essential oil (dried drug).a) Traditional herbal medicinal product used in
temporary loss of appetite.
b) Traditional herbal medicinal product used in
mild dyspeptic/gastrointestinal disorders.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
· · ·1. Wormwood effect of steroid-sparing in Crohn's disease (Omer, 2007(489)) 2. Wormwood suppresses tumour necrosis factor alpha and accelerates healing in patients with Crohn's disease (Krebs, 2010)(490)
Yarrow (Millefolii herba) 07/2014:1382Whole or cut, dried flowering tops of Achillea millefolium L.– essential oil: minimum 2 mL/kg (dried drug);
– proazulenes, expressed as chamazulene (C14H16 ; Mr 184.3) : minimum 0.02 per cent (dried drug).
Indication 1)
Traditional herbal medicinal product used for
temporary loss of appetite.
Indication 2)
Traditional herbal medicinal product for the
symptomatic treatment of mild, spasmodic gastrointestinal
complaints including bloating, and
flatulence.
Indication 3)
Traditional herbal medicinal product for the
symptomatic treatment of minor spasm
associated with menstrual periods.
Indication 4)
Traditional herbal medicinal product for the
treatment of small superficial wounds.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Orally for loss of appetite, common cold, dyspeptic ailments such as mild
spastic discomfort of the gastrointestinal tract, as a choleretic and for the treatment of fevers. Externally for skin inflammation and
wounds.
Externally as a sitz bath for treatment of painful, cramp-like conditions
due to menstrual disorders
Orally as an emmenagogue, eyewash, haemostat, laxative, sleep aid, stimulant
tonic, and to treat baldness, prostatitis and vertigo.
Used externally for the treatment of haemorrhoids, haematoma and
burn injuries
INTERNAL USE: Loss of appetite; dyspeptic disorderrs such as mild spasmodic complaints of the abdominal region [7]. EXTERNAL USE: Supportive treatment of small wounds; mild inflammations of the skin and mucous membranes [3, 7] as an insect repellent [48, 49]. 1. Yarrow preparation (and much more) applied in the treatment of gastric hyperacidity, gastric and duodenal ulcer in cigarette smokers (Gawron-Gzella, 2005)(494) 2. Yarrow on relief of primary dysmenorrhea (Jenabi, 2015)(493) 3. Yarrow on plasma nitrite and nitrate levels in patients with chronic kidney disease (Vahid, 2012)(491) 4. Minireview of Yarrow (Akram, 2013)(495) 5. Achillea millefolium on mouthwash on chemotherapy induced oral mucositis in cancer patients, study (Miranzadeh, 2015)(492)
Yarrow Flower (Millefolii flos)Indication 1) Traditional herbal medicinal product used for
temporary loss of appetite. Indication 2)
Traditional herbal medicinal product for the
symptomatic treatment of mild, spasmodic gastrointestinal
complaints including bloating and
flatulence.
Indication 3)
Traditional herbal medicinal product for the
treatment of small superficial wounds.
Indication 4)
Traditional herbal medicinal product for the
symptomatic treatment of minor spasm
associated with menstrual periods.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
Yeast (Saccharomyces cerevisiae CBS 5926)1. accuracy of interferon-gamma releasing assay and anti-Saccharomyces cerevisiae antibody in differentiating intestinal tuberculosis from Crohn's disease in asians (Ng, 2014)(498) 2. Yeast, serological markers and its risk of acute and chronic pouchitis (Singh, 2013)(497) 3. Study that proposes a new approach in shrinking the solution space of a genome-scale model, of which sampling provides new insights into gene expression noise (Chi, 2015)(500) 4. Yeast as supplementation on glycated hemoglobin and fasting plasma glucose in patients with diabetes mellitus (Yin, 2015)(496) 5. Use of Yeast to prevent the pediatric antibiotic-associated diarrhea (Hayes, 2016)(499)
Zanthoxlylum bungeanum pericarp (Zantoxyli bungeani pericarpium) 01/2017:2656Dried pericarp of the ripe fruit, with seeds removed, of
Zanthoxylum bungeanum Maxim.
minimum 15 mL/kg of essential oil (anhydrous
drug).

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