Herbs drugs from EMA

Latin name of herbal substance Botanical name of plant English common name of herbal substance Definition in European Pharmacopeia Use Therapeutic indications Link
Ginkgo folium Ginkgo biloba L. Ginkgo leaf The herbal substance consists of the whole or fragmented, dried leaf of Ginkgo biloba L.Herbal preparation(s) 1. Ginkgo biloba dry extract is a component part of the European Pharmacopoeia. Actually the following monograph exists: Assessment report on Ginkgo biloba L., folium EMA/HMPC/321095/2012 Page 4/120 - Ginkgo dry extract, refined and quantified (Ph. Eur. 7th edition 2012 (7.5), ref. 04/2008:1827) This extract contains several chemical constituents, among which the two main constituents �flavones glycosides� (total 22.0-27.0%), represented by quercetin, kaempherol and isorhamnetin and �terpene lactones� (total 5.0-7.0), represented by ginkgolides A, B, C (2.8- 3.4%) and bilobalide (2.6-3.2%). The content of ginkgolic acids is limited with max. 5 ppm. The limit value of 5 ppm was chosen since it complies with the detection limit recordable by routine methods, thus allowing to assure to a maximum degree removal of these compounds from therapeutically used extracts. Circulatory disorders Herbal medicinal product for the improvement of (age-associated) cognitive impairment and of quality of life in mild dementia. https://www.ema.europa.eu/en/medicines/herbal/ginkgo-folium
Hippocastani semen Aesculus hippocastanum L. Horse-Chestnut Seed The herbal substance is the whole or fragmented, dried, ripe seeds of Aesculus hippocastanum L. According to the definition in the Ph. Eur., the herbal substance should contain a minimum 1.5% of triterpene glycosides, expressed as protoaescigenin Circulatory disorders 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. https://www.ema.europa.eu/en/medicines/herbal/hippocastani-semen
Myrtilli fructus recens Vaccinium myrtillus L. Fresh Bilberry fruit Vaccinium myrtillus (L.), fructus siccus (bilberry fruit, dried): dried ripe fruit of V. myrtillus (L.) (Ph. Eur. 8.0, 2008:1588). It contains minimum 1.0% of tannins expressed as pyrogallol. Vaccinium myrtillus (L.), fructus recens (bilberry fruit, fresh): fresh or frozen ripe fruit of V. myrtillus (L.) (Ph. Eur. 8.0, 2008:1602). It contains minimum 0.30% of antocyanins, expressed as cyanidin 3- O-glucoside chloride Circulatory disorders 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. https://www.ema.europa.eu/en/medicines/herbal/myrtilli-fructus-recens
Rusci aculeati rhizoma Ruscus aculeatus L. Butcher's Broom Vaccinium myrtillus (L.), fructus siccus (bilberry fruit, dried): dried ripe fruit of V. myrtillus (L.) (Ph. Eur. 8.0, 2008:1588). It contains minimum 1.0% of tannins expressed as pyrogallol. Vaccinium myrtillus (L.), fructus recens (bilberry fruit, fresh): fresh or frozen ripe fruit of V. myrtillus (L.) (Ph. Eur. 8.0, 2008:1602). It contains minimum 0.30% of antocyanins, expressed as cyanidin 3- O-glucoside chloride Circulatory disorders 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. https://www.ema.europa.eu/en/medicines/herbal/rusci-aculeati-rhizoma
Vitis viniferae folium Vitis vinifera L. Grapevine Leaf The herbal substance Vitis vinifera L., folium, (Vitaceaea) consists of the dried leaves of the black to pulp-red grapevine and has a faintly perceptible odour. The herbal drug is harvested by hand in the autumn following the grape harvest. Drying takes place under natural conditions in accordance with local climatic conditions. Powdered dried Leaf, Corresponding to 8% total polyphenols and Minimum 0.20% Of anthocyanosides (WEU Belgium) Circulatory disorders 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. https://www.ema.europa.eu/en/medicines/herbal/vitis-viniferae-folium
Rosmarini aetheroleum Rosmarinus officinalis L. Rosemary Oil Herbal substance(s) Whole or cut dried leaf of Rosmarinus officinalis L. (Ph. Eur. monograph ref.:01/2008:1560) ? Herbal preparation(s) Comminuted herbal substance Liquid extracts Expressed juice Essential oil ? Combinations of herbal substance(s) and/or herbal preparation(s) including a description of vitamin(s) and/or mineral(s) as ingredients of traditional combination herbal medicinal products assessed, where applicable. In the European Pharmacopoeia, the density of rosemary essential oil is reported as 0.895 to 0.920 (M/V) -> approximately 0.90. The leaves contain 0.5 to 2.5 % of a volatile oil, consisting of 0.8-6 % esters and 8-20 % free alcohols
(Chandler, 1995).
Circulatory disorders, Gastrointestinal disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/rosmarini-aetheroleum
Rosmarini folium Rosmarinus officinalis L. Rosemary leaf Herbal substance(s) Whole or cut dried leaf of Rosmarinus officinalis L. (Ph. Eur. monograph ref.:01/2008:1560) ? Herbal preparation(s) Comminuted herbal substance Liquid extracts Expressed juice Essential oil ? Combinations of herbal substance(s) and/or herbal preparation(s) including a description of vitamin(s) and/or mineral(s) as ingredients of traditional combination herbal medicinal products assessed, where applicable. In the European Pharmacopoeia, the density of rosemary essential oil is reported as 0.895 to 0.920 (M/V) -> approximately 0.90. Circulatory disorders, Gastrointestinal disorders 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. https://www.ema.europa.eu/en/medicines/herbal/rosmarini-folium
Crataegi folium cum flore Crataegus spp. Hawthorn Leaf and Flower Herbal substance(s) A monograph of hawthorn leaf and flower is published in the European Pharmacopoeia (2014a): Whole or cut, dried flower-bearing branches of Crataegus monogyna Jacq. (Lindm.), Crataegus laevigata (Poir.) DC. (syn. Crataegus oxyacanthoides Thuill.; Crataegus oxyacantha auct.) or their hybrids or, more rarely, other European Crataegus species including Crataegus pentagyna Waldst. et Kit. ex Willd., Crataegus nigra Waldst. et Kit. and Crataegus azarolus L. It contains minimum 1.5% of total flavonoids, expressed as hyperoside (dried drug). Circulatory disorders, Mental stress and mood disorders Indication 1) Traditional herbal medicinal product used to relieve symptoms of temporary nervous cardiac complaints (e.g. palpitations, perceived extra heart beat due to mild anxiety) after serious conditions have been excluded by a medical doctor. Indication 2) 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. https://www.ema.europa.eu/en/medicines/herbal/crataegi-folium-cum-flore
Leonuri cardiacae herba Leonurus cardiaca L. Motherwort Leonuri cardiacae herba, Motherwort Ph. Eur. 6.0: Whole or cut, dried flowering parts of Leonurus cardiaca L. Content: minimum 0.2% of flavonoids, expressed as hyperoside (Ph. Eur. 01/2008:1833 corrected 6.0). Circulatory disorders, Mental stress and mood disorders 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. https://www.ema.europa.eu/en/medicines/herbal/leonuri-cardiacae-herba
Aloes folii succus siccatus Aloe barbadensis Mill. and Aloe (various species) Aloes Barbados aloes consists of the concentrated and dried juice of the leaves of Aloe barbadensis Mill. It contains not less than 28% of hydroxyanthracene derivatives (HAD) expressed as barbaloin (C21H22O9; Mr 418.4) and calculated with reference to the dried herbal substance. The material complies with the European Pharmacopoeia monograph �Aloes, Barbados� (0257). Constipation Herbal medicinal product for short-term use in cases of occasional constipation https://www.ema.europa.eu/en/medicines/herbal/aloes-folii-succus-siccatus
Frangulae cortex Rhamnus frangula L. Frangula bark It contains not less than 7% of glucofrangulins, expressed as glucofrangulin A (C27H30O14; Mr 578.5) and calculated with reference to the dried herbal substance. The material complies with the European Pharmacopoeia monograph �Frangula bark� (ref. Ph. Eur. 9:0025). Constipation Herbal medicinal product for short-term use in https://www.ema.europa.eu/en/medicines/herbal/frangulae-cortex
Plantaginis ovatae semen Plantago ovata Forssk. Ispaghula Seed The German Pharmacopoeia indicates that ispaghula seed has to be capable of absorbing at least 9 times its own weight in water. The British Pharmacopoeia indicates at least 12 times. The European Pharmacopoeia requests a swelling index of minimum 9. High-quality seeds are capable of absorbing 14 to 19 times their own weight of water (Blaschek et al. 2003). Constipation 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 https://www.ema.europa.eu/en/medicines/herbal/plantaginis-ovatae-semen
Plantaginis ovatae seminis tegumentum Plantago ovata Forssk. Ispaghula husk European Pharmacopoeia. Ispaghula husk consists of 85% water-soluble fibre. The active polysaccharidic fraction comprises 65% D-xylose, 20% L-arabinose, 6% rhamnose and 9% D-galacturonic acid (3). The polysaccharide is shown to be a highly branched acidic arabinoxylan, the xylan backbone having both 1?4 and 1?3 sugar linkages. Constipation Indication 1) Herbal medicinal product for the treatment of habitual constipation. Indication 2) Herbal medicinal product in conditions in which https://www.ema.europa.eu/en/medicines/herbal/plantaginis-ovatae-seminis-tegumentum
Psyllii semen Plantago afra L.; Plantago indica L. Psyllium seed The active ingredients are the mucilages like in ispaghula husk and seed. The European Pharmacopoeia monograph requests that the swelling index should be �not less than 10�. High-quality psyllium seeds are capable of absorbing 14 to 19 times their own weight of water (Blaschek et al. 2003, Sharma & Koul 1986). Constipation Indication 1) Herbal medicinal product for the treatment of habitual constipation. Indication 2) Herbal medicinal product in conditions in which https://www.ema.europa.eu/en/medicines/herbal/psyllii-semen
Rhamni purshianae cortex Rhamnus purshianus D.C. Cascara Cascara consists of the dried, whole or fragmented bark of Rhamnus purshiana DC. (Frangula purshian Benichou a (DC.) A. Gray. It contains not less than 8.0% of hydroxyanthracene glycosides of which not less than 60% consists of cascarosides, both expressed as cascarosides A (C27H32O14; Mr 580.5) and calculated with reference to the dried herbal substance. This complies with the European Pharmacopeia monograph �Cascara Bark� (Ph. Eur. 9:0105) Constipation Herbal medicinal product for short-term use in cases of occasional constipation. https://www.ema.europa.eu/en/medicines/herbal/rhamni-purshianae-cortex
Rhei radix Rheum palmatum L.; Rheum officinale Baillon Rhubarb Rhubarb root consists of the whole or cut, dried underground parts of Rheum palmatum L. or Rheum officinale Baillon or of hybrids these two species or a mixture. The underground parts are often divided; the stem and most of the bark with the rootlets are removed. It contains not less than 2.2% of hydroxyanthracene derivatives, expressed as rhein (C15H8O6, Mr 284.2), calculated with reference to the dried herbal substance according to European Pharmacopoeia (European Pharmacopoeia 9:0291). Constipation Herbal medicinal product for short-term use in cases of occasional constipation. https://www.ema.europa.eu/en/medicines/herbal/rhei-radix
Sennae folium Cassia senna L.; Cassia angustifolia Vahl Senna leaf Senna alexandrina Mill. has recently been identified as the correct name of a plant species (www.theplantlist.org; Wichtl, 2016), which had been classified before as two different species, Cassia senna L. and Cassia angustifolia Vahl. These two species had already been known as very closely related. It is also intended to use Senna alexandrina Mill. in the respective monographs of the European Pharmacopeia and therefore the European monographs have been renamed accordingly. Leaves and fruits of both species contain a similar spectrum of hydroxyanthracene derivatives, which are accepted as the active constituents. Constipation Herbal medicinal product for short-term use in https://www.ema.europa.eu/en/medicines/herbal/sennae-folium
Sennae fructus Cassia senna L.; Cassia angustifolia Vahl Senna pods The herbal substance senna leaves consist of the dried leaflets of Cassia senna L. (Cassia acutifolia Del.), known as Alexandrian or Khartoum senna, or Cassia angustifolia Vahl, known as Tinnevelly senna, or a mixture of the two species, now collectively subsumed under the item Senna alexandrina Mill. The herbal substance contains not less than 2.5% of hydroxyanthracene glycosides, calculated as sennoside B (C42H38O20; Mr 863). The material complies with the European Pharmacopoiea monograph �Senna leaf� (Ph. Eur. 9: 0206). The active constituents are the anthranoids that are present in the leaf of the herbal substance as dianthrones (75�80%) and as anthrones (20�25%). Constipation Herbal medicinal product for short-term use in cases of occasional constipation. Indication 2) Herbal medicinal product for bowel cleansing prior to clinical procedures requiring bowel preparation. https://www.ema.europa.eu/en/medicines/herbal/sennae-fructus
Lini semen Linum usitatissimum L. Linseed The herbal substance senna leaves consist of the dried leaflets of Cassia senna L. (Cassia acutifolia Del.), known as Alexandrian or Khartoum senna, or Cassia angustifolia Vahl, known as Tinnevelly senna, or a mixture of the two species, now collectively subsumed under the item Senna alexandrina Mill. The herbal substance contains not less than 2.5% of hydroxyanthracene glycosides, calculated as sennoside B (C42H38O20; Mr 863). The material complies with the European Pharmacopoiea monograph �Senna leaf� (Ph. Eur. 9: 0206). The active constituents are the anthranoids that are present in the leaf of the herbal substance as dianthrones (75�80%) and as anthrones (20�25%). Constipation, Gastrointestinal disorders Herbal medicinal product for the treatment of habitual constipation or in conditions in which easy defaecation with soft stool is desirable. https://www.ema.europa.eu/en/medicines/herbal/lini-semen
Combination: Thymi herba and Primulae radix Combination: Thymus vulgaris L.; Thymus zygis L. and Primula veris L.; Primula elatior (L.) Hill Thyme and Primula root The phytochemical composition of both Thyme and Primula root and their preparations have been discussed in the assessment reports on Thyme (Doc. Ref. EMA/HMPC/342334/2013) Thyme essential oil (Doc. Ref. EMA/HMPC/131903/2009) Primula root (Doc. Ref. EMA/HMPC/113577/2012). Cough and cold Herbal medicinal product used as an expectorant in case of productive cough https://www.ema.europa.eu/en/medicines/herbal/combination-thymi-herba-primulae-radix
Echinaceae angustifoliae radix Echinacea angustifolia DC. Narrow-leaved coneflower root Echinaceae angustifoliae radix (European Pharmacopoeia monograph ref.: 01/2008:1821) Echinaceae angustifoliae radix consists of the whole or cut, dried underground parts of Echinacea angustifolia DC. It contains not less than 0.5% of echinacoside (C35H46O20; Mr 786.5). Cough and cold 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. https://www.ema.europa.eu/en/medicines/herbal/echinaceae-angustifoliae-radix
Echinaceae pallidae radix Echinacea pallida (Nutt.) Nutt. Pale Coneflower Root These herbal preparations are not described in any available pharmacopoeia or handbook. Herbal preparation similar but not identical to herbal preparation B) was phytochemically investigated (Senchina et al., 2011). The investigated herbal preparation was extracted from fresh roots of Echinacea pallida with 50% V/V ethanol, but the ratio of herbal substance to extraction solvent was 1:9. Cough and cold Traditional herbal medicinal product for the relief of symptoms of common cold. The product is a traditional herbal medicinal https://www.ema.europa.eu/en/medicines/herbal/echinaceae-pallidae-radix
Eucalypti folium Eucalyptus globulus Labill. Eucalyptus leaf European Pharmacopoeia 7th ed. 2011 (7.1), British Herbal Compendium 2006 [Bradley 2006], Real Farmacopea Espanola 2002 and according to the Deutsches Arzneibuch DAB 10 (German Pharmacopoeia): �Eucalyptus leaves are the whole or cut dried leaves of older branches of Eucalyptus globulus Labill. Content: minimum 20 ml/kg of essential oil for the whole drug (anhydrous drug) and minimum 15 ml/kg of essential oil for the cut drug (anhydrous drug).� Cough and cold Traditional herbal medicinal product used for relief of cough associated with cold. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. https://www.ema.europa.eu/en/medicines/herbal/eucalypti-folium
Foeniculi amari fructus aetheroleum Foeniculum vulgare Miller subsp. vulgare var. vulgare Bitter Fennel Fruit Oil The monographs of �Foeniculi amari fructus�, of �Foeniculi dulcis fructus� and of �Bitterfennel fruit oil� present in the current (5th edition) of the European Pharmacopoeia and of sweet-fennel fruit oil (�Foeniculi aetheroleum�) in the Italian Pharmacopoeia (XI Ed.); Cough and cold 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. https://www.ema.europa.eu/en/medicines/herbal/foeniculi-amari-fructus-aetheroleum
Grindeliae herba Grindelia robusta Nutt. Gumweed herb Grindeliae herba (gumweed herb) consists of the dried flowering tops of Grindelia robusta Nutt., Grindelia squarrosa Dunal, Grindelia humilis Hook. et Arn., Grindelia camporum Greene or a mixture of them (Pharmacop�e Fran�aise 1998; ESCOP 2009). Cough and cold Traditional herbal medicinal product for relief of cough associated with cold. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. https://www.ema.europa.eu/en/medicines/herbal/grindeliae-herba
Hederae helicis folium Hedera helix L. Ivy leaf Diverse national monographs for Hederae folium have been replaced by the current European Pharmacopoeia 9th edition 2017. Hederae folium are the whole or cut, dried leaves of Hedera helix L., collected in spring. Content: minimum 3.0% of hederacoside C (C59H96O26; Mr 1221). Cough and cold Herbal medicinal product used as an expectorant in case of productive cough. https://www.ema.europa.eu/en/medicines/herbal/hederae-helicis-folium
Pelargonii radix Pelargonium sidoides DC; Pelargonium reniforme Curt. Pelargonium root By comparative botanical as well as chromatographic studies, it could be proven that two species i.e. Pelargonium sidoides or Pelargonium reniforme were used for the same purposes. These Pelargonium species are very similar and have been much confused in the past. The existence of gradual variation between both species contributed to general problems of taxonomic classification, as reflected in the past by numerous revisions of the Linneaen taxonomic system (Kolodziej, 2002; van Wyk, 2008). The use of both species is also accepted by the European Pharmacopoeia monograph describing Pelargonium sidoides DC and/or Pelargonium reniforme Curt. in one monograph without defining specific parameters for differentiation (European Pharmacopoeia, 2016) Cough and cold Posology Single dose Adolescents over the age of 12 years, adults and elderly a) Liquid extract: 1.19-1.25 ml, 3 times daily. b) Dry extract: 20 mg, 3 times daily. Children between 6-12 years a) Liquid extract: 0.79-0.83 ml, 3 times daily. b) Dry extract: 20 mg, 2 times daily. The use in children under 6 years of age is not recommended (see section 4.4 �Special warnings and precautions for use�). Duration of use If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Oral use https://www.ema.europa.eu/en/medicines/herbal/pelargonii-radix
Plantaginis lanceolatae folium Plantago lanceolata L. Ribwort Plantain European Pharmacopoeia 6th ed. 2010 (6.7): �Plantaginis lanceolatae folium - Ribwort plantain� �Whole or fragmented, dried leaf and scape of Plantago lanceolata L.s.l.� Cough and cold 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
https://www.ema.europa.eu/en/medicines/herbal/plantaginis-lanceolatae-folium
Primulae flos Primula veris L.; Primula elatior (L.) Hill Primula flower Some references restrict the plant source to the species Primula veris (British Herbal Pharmacopoeia (1974), Pharmacop�e Fran�aise X�me �dition). Cough and cold 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 https://www.ema.europa.eu/en/medicines/herbal/primulae-flos
Primulae radix Primula veris L.; Primula elatior (L.) Hill Primula root Primula root (Primulae radix) consists of the whole or cut, dried rhizome and root of Primula veris L. or Primula elatior (L.) Hill as described in the European Pharmacopoeia (European Pharmacopoeia 2008). Cough and cold 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. https://www.ema.europa.eu/en/medicines/herbal/primulae-radix
Sambuci flos Sambucus nigra L. Elder Flower Elder flower (Sambuci flos) consists of the dried flowers of Sambucus nigra L. It contains not less than 0.80% of flavonoids, calculated as isoquercitroside (C21H20O12; Mr464.4) with reference to the dried drug (Ph. Eur., ref.: 1217). Cough and cold Traditional herbal medicinal product used for the relief of early symptoms of common cold. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. https://www.ema.europa.eu/en/medicines/herbal/sambuci-flos
Thymi aetheroleum Thymus vulgaris L.; Thymus zygis Loefl. ex L. Thyme oil Essential oil: there are at least 6 chemotypes of Thymus vulgaris L. (Thompson et al. 2003) with different compositions of the essential oil; only the �thymol�-type with thymol as predominant compound complies with the definition in the European Pharmacopoeia. The dried herbal substance contains up to 2.5% essential oil; the main components are thymol, p-cymene, carvacrol, ? -terpinene, linalool, ? - myrcene, terpinen-4-ol. Some compounds occur partly as glycosides (e.g. p-cymene-9-ol) (Takeuchi et al. 2004, Kitajima et al. 2004, Stahl-Biskup 1991). Cough and cold Traditional herbal medicinal product used as an expectorant in cough associated with cold. 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.
https://www.ema.europa.eu/en/medicines/herbal/thymi-aetheroleum
Allii sativi bulbus Allium sativum L. Garlic For garlic powder, the European Pharmacopoeia prescribes no less than 0.45% of allicin (dry drug) (Eur. Ph., 2019). Cough and cold, Circulatory disorders Traditional herbal medicinal product used as an
adjuvant for the prevention of atherosclerosisTraditional 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.
https://www.ema.europa.eu/en/medicines/herbal/allii-sativi-bulbus
Polypodii rhizoma Polypodium vulgare L. Polypody Rhizome However, according to the botanical description of Polypodium vulgare L., the correct designation for this plant part should be rhizome and not root. A root has two main functions: anchoring the plant in the soil and absorbing water and minerals. Cough and cold, Constipation ) 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. https://www.ema.europa.eu/en/medicines/herbal/polypodii-rhizoma
Anisi aetheroleum Pimpinella anisum L. Anise Oil The essential oil obtained by steam distillation from the dry ripe fruits is also used. Separate monographs are published in the European Pharmacopeia for aniseed and anise oil. The essential oil is a clear, colourless or pale yellow liquid, obtained by steam distillation of dry ripe fruits (European Pharmacopeia 7th Ed); it varies between 1.5% and 6% v/w and contains mainly transanethole (80-95%) (H�nsel et al., 1994; Schultze et al., 1987; Shojaii & Mehri, 2012). Cough and cold, Gastrointestinal disorders Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastrointestinal complaints including bloating and flatulence. https://www.ema.europa.eu/en/medicines/herbal/anisi-aetheroleum
Anisi fructus Pimpinella anisum L. Aniseed Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastrointestinal complaints including bloating and flatulence. Cough and cold, Gastrointestinal disorders Traditional herbal medicinal product for
symptomatic treatment of mild, spasmodic gastrointestinal complaints including bloating and
flatulence. 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.
https://www.ema.europa.eu/en/medicines/herbal/anisi-fructus
Liquiritiae radix Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch. Liquorice Root Liquorice root consists of the dried unpeeled or peeled, whole or cut root and stolons of Glycyrrhiza glabra L and/or of Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch.. It contains not less than 4.0 per cent of 18 ?-glycyrrhizic acid (C42H62O16, Mr 823), calculated with reference to the dried drug (European Pharmacopoeia 2010). Cough and cold, Gastrointestinal disorders Indication 1 Traditional herbal medicinal product for the relief of digestive symptoms including burning sensation and dyspepsia. 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. https://www.ema.europa.eu/en/medicines/herbal/liquiritiae-radix
Malvae folium Malva sylvestris L. Mallow leaf Indication 1)
Traditional herbal medicinal product used as a
demulcent preparation for the symptomatic
treatment of oral or pharyngeal irritation and
associated dry cough.
Indication 2)
Traditional herbal medicinal product used as a
Cough and cold, Gastrointestinal disorders Indication 1)
Traditional herbal medicinal product used as a
demulcent preparation for the symptomatic
treatment of oral or pharyngeal irritation and
associated dry cough.
Indication 2)
Traditional herbal medicinal product used as a
https://www.ema.europa.eu/en/medicines/herbal/malvae-folium
Malvae sylvestris flos Malva sylvestris L. Mallow flower The flower consists of an epicalyx with 3 oblong or ellipticallanceolate parts that are shorter than those of the calyx and situated immediately below it; a calyx with 5 pubescent triangular lobes, gamosepalous at the base; a corolla 3-4 times longer than the calyx with 5 wedge-shaped. Cough and cold, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/malvae-sylvestris-flos
Sideritis herba Sideritis scardica Griseb.; Sideritis clandestina (Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Ironwort Cough and cold, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/sideritis-herba
Tiliae flos Tilia cordata Miller Lime flower Cough and cold, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/tiliae-flos
Sisymbrii officinalis herba Sisymbrium officinale (L.) Scop. Hedge mustard Cough and cold, Mouth and throat disorders Herbal medicinal product used as an expectorant in case of productive cough https://www.ema.europa.eu/en/medicines/herbal/sisymbrii-officinalis-herba
Camelliae sinensis non fermentatum folium Camellia sinensis (L.) Kuntze Green tea Green tea leaf (Camelliae sinensis non fermentatum, folium) consists of whole or cut young,
unfermented, rapidly hot dried leaf of Camellia sinensis (L.) Kuntze and its cultivated varieties. It
contains not less than 2.0% of caffeine (C8H10N4O2, Mr 194,2) (dried drug) (French Pharmacopoeia,
2010).
Fatigue and weakness Traditional herbal medicinal product for relief of
fatigue and sensation of weakness.
https://www.ema.europa.eu/en/medicines/herbal/camelliae-sinensis-non-fermentatum-folium
Colae semen Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl. Cola Fatigue and weakness https://www.ema.europa.eu/en/medicines/herbal/colae-semen
Eleutherococci radix Eleutherococcus senticosus (Rupr. et Maxim.) Maxim. Eleutherococcus Fatigue and weakness https://www.ema.europa.eu/en/medicines/herbal/eleutherococci-radix
Ginseng radix Panax ginseng�C. A. Meyer. Ginseng Ginseng radix consists of the whole or cut dried root, designated white ginseng, treated with steam and then dried, designated red ginseng, of Panax ginseng C.A. Meyer and contains not less than 0.40% for the sum of ginsensosides Rg1 and Rb1 (dried drug). Fatigue and weakness 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. https://www.ema.europa.eu/en/medicines/herbal/ginseng-radix
Lecithinum ex soya Glycine max (L.) Merr. Soya-bean lecithin Fatigue and weakness https://www.ema.europa.eu/en/medicines/herbal/lecithinum-ex-soya
Paulliniae semen Paullinia cupana Kunth ex H.B.K. var sorblis (Mart.) Ducke Guarana seed Fatigue and weakness https://www.ema.europa.eu/en/medicines/herbal/paulliniae-semen
Rhodiolae roseae rhizoma et radix Rhodiola rosea L. Arctic root Fatigue and weakness, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/rhodiolae-roseae-rhizoma-et-radix
Mate folium Ilex paraguariensis St. Hilaire Mat� Leaf Fatigue and weakness, Urinary tract and genital disorders https://www.ema.europa.eu/en/medicines/herbal/mate-folium
Boldi folium Peumus boldus Molina Boldo Leaf Peumus boldus Molina, folium Boldo leaf (boldi folium) is defined in the European Pharmacopoeia as the whole or fragmented dried leaf of Peumus boldus Molina. It contains not less than 0.1% of total alkaloids, expressed as boldine (C19H21 NO4; Mr 327.4), calculated with reference to the anhydrous drug. Boldo leaf contains 2-4% of volatile oil. Major constituents are reported as: ascaridole (16-38%), 1,8 cineole (11-39%) and p-cymene (9-29%) (Bradley, 2006). Ascaridole is highly toxic (see Section 3.3.7) and this raises concerns about the suitability of boldo leaf in traditional herbal medicinal products. Gastrointestinal disorders Traditional herbal medicinal product used for
symptomatic relief of dyspepsia and mild
https://www.ema.europa.eu/en/medicines/herbal/boldi-folium
Carvi aetheroleum Carum carvi�L. Caraway oil Caraway fruit is the whole, dry mericarp of Carum carvi L. and should contain a minimum 30 ml/kg of
essential oil (anhydrous drug) in accordance with the European Pharmacopeia (01/2008:1080).
Gastrointestinal disorders Traditional herbal medicinal product for the
symptomatic relief of digestive disorders such as
bloating and flatulence.
https://www.ema.europa.eu/en/medicines/herbal/carvi-aetheroleum
Carvi fructus Carum carvi�L. Caraway fruit Caraway fruit is the whole, dry mericarp of Carum carvi L. and should contain a minimum 30 ml/kg of
essential oil (anhydrous drug) in accordance with the European Pharmacopeia (01/2008:1080).
Gastrointestinal disorders 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
https://www.ema.europa.eu/en/medicines/herbal/carvi-fructus-0
Carvi fructus Carum carvi�L. Caraway fruit Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/carvi-fructus
Chamomillae romanae flos Chamaemelum nobile (L.) All. (Anthemis nobilis L.) Roman Chamomile Flower Dried flowers of the cultivated double flowered variety of Chamaemelum nobile (L.) All. (syn. Anthemis
nobilis L.) [Fam. Asteraceae]. It contains not less than 7 ml/kg of essential oil. (Ph. Eur. 6, 2008)
Gastrointestinal disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/chamomillae-romanae-flos
Cinnamomi cortex Cinnamomum verum J. S. Presl Cinnamon Cinnamomum verum J. S. Presl. (=Cinnamomum zeylanicum Nees), dried bark, freed from the
outer cork and the underlying parenchyma (ESCOP, 2003; European Pharmacopoeia 6.2, 2009).
Gastrointestinal disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/cinnamomi-cortex
Cinnamomi corticis aetheroleum Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees) Cinnamon Bark Oil Cinnamomum verum J. S. Presl. (=Cinnamomum zeylanicum Nees), dried bark, freed from the
outer cork and the underlying parenchyma (ESCOP, 2003; European Pharmacopoeia 6.2, 2009).
Gastrointestinal disorders 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 indication exclusively based upon long-standing use. https://www.ema.europa.eu/en/medicines/herbal/cinnamomi-corticis-aetheroleum
Curcumae longae rhizoma Curcuma longa L. Turmeric The European Pharmacopoeia defines Curcumae longae rhizoma or turmeric rhizome as the whole,
cured (by boiling or steaming), dried rhizome of Curcuma longa L. (syn. Curcuma domestica Valeton)
with roots and outer surface removed (European pharmacopoeia 8th ed. 2017).
Gastrointestinal disorders Traditional herbal medicinal product used for the
relief 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.
https://www.ema.europa.eu/en/medicines/herbal/curcumae-longae-rhizoma
Curcumae xanthorrhizae rhizoma Curcuma xanthorrhiza Roxb. (C.�xanthorrhiza D.�Dietrich). Javanese turmeric Curcumae xanthorrhizae rhizoma consists of the dried rhizome, cut in slices, of Curcuma xanthorrhiza
Roxb. (C. xanthorrhiza D. Dietrich). The raw material is described in the Ph. Eur. Monograph 1441
Curcumae xanthorrhizae rhizoma (Ph. Eur. 1441).
Gastrointestinal disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/curcumae-xanthorrhizae-rhizoma
Cynarae folium Cynara scolymus L. Artichoke Leaf According European pharmacopoeia, Ed. 9.0 (ref.: 1866) the name of the botanical species Cynara
scolymus L. changed to Cynara cardunculus L. Pharmacopoeial grade artichoke leaf consists of the
dried basal leaves of Cynara cardunculus L. containing a minimum 0.8% of chlorogenic acid (C16H18O9;
Mr 354.3) (dried drug).
Gastrointestinal disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/cynarae-folium
Fucus vesiculosus, thallus Fucus vesiculosus L. (bladderwrack) grows on rocky shores in areas with cold and temperate
climate, mostly at North American and Western European shores of the North Atlantic and the
Pacific Ocean (Verhelst 2010). Fucus vesiculosus is a small brown seaweed measuring
20 to 100 centimetres in length. Their flat thallus branches dichotomously. Oval with air filled
bubbles in the membraneous parts make the seaweed float vertically. This seaweed is harvested at
the start of summer (Verhelst 2010, De Smet et al. 1997).
? Minerals: iodine (mostly bound in organic substances), with a minimum of 0.03 and a
maximum 0.2 per cent of total iodine determined on the dried drug. (European Pharmacopoeia
7.0, Delfosse 1998, Williamson 2009; Ulbricht et al. 2013).
Gastrointestinal disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/fucus-vesiculosus-thallus
Fumariae herba Fumaria officinalis L. Fumitory According to the European Pharmacopoeia (6th ed. 2008), the whole or fragmented dried aerial parts of
Fumaria officinalis are harvested in full bloom. They contain a minimum of 0.40% of total alkaloids,
expressed as protopine (C20H19NO5=353.4).
Gastrointestinal disorders Traditional use
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.
https://www.ema.europa.eu/en/medicines/herbal/fumariae-herba
Gentianae radix Gentiana lutea L. Gentian Root �Dried, fragmented underground organs of Gentiana lutea L., with a characteristic odour and a strong
and persistent bitter taste. Gentian root occurs as single or branched subcylindrical pieces of various
lengths and usually 10-40 mm thick but occasionally up to 80 mm thick at the crown.�
Gastrointestinal disorders Indication 1) Traditional herbal medicinal product for temporary loss of appetite. Indication 2) Traditional herbal medicinal product for mild dyspeptic/gastrointestinal disorders. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. https://www.ema.europa.eu/en/medicines/herbal/gentianae-radix
Helichrysi flos Helichrysum arenarium (L.) Moench Sandy everlasting According to Flora Europaea (Clapham et al., 1976, monograph on Helichrysum Miller) Helichrysum
Arenarium (L.) Moench is a herbaceus perennial 8-30 (-50) cm. Plant not sweet-smelling.
Gastrointestinal disorders Traditional herbal medicinal product used in
digestive disorders with a feeling of fullness and
bloating.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use
https://www.ema.europa.eu/en/medicines/herbal/helichrysi-flos
Menthae piperitae aetheroleum Mentha x piperita L. Peppermint oil According to the European Pharmacopoeia, it contains a minimum of 12 ml/kg of essential oil for the
whole drug and a minimum of 9 ml/kg of essential oil for the cut drug (Ph. Eur. Ref.: 0406).
Gastrointestinal disorders Traditional use
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 the specified indication
exclusively based upon long-standing use.
https://www.ema.europa.eu/en/medicines/herbal/menthae-piperitae-aetheroleum
Ricini oleum Ricinus communis L. Castor oil According to the European Pharmacopeia, castor oil should contain max. 2% palmitic acid, max. 2.5% stearic acid, 2.5-6.0% oleic acid and isomers, 2.5- 7.0% linoleic acid, max. 1% linolenic acid, max. 1% eicosenoic acid, 85-92% ricinoleic acid and max. 1% any other fatty acid (Ph. Eur. 01/2013:0051 and Ph. Eur. 01/2013:2367). Gastrointestinal disorders Well-established use: Laxative for short term use in cases of occasional
Constipation.
https://www.ema.europa.eu/en/medicines/herbal/ricini-oleum
Silybi mariani fructus Silybum marianum�L. Gaertner Milkthistle Fruit Silybum marianum (L.) Gaertn., fructus, is included in the European Pharmacopeia and some national
pharmacopeias. Currently the following monographs exist:
- Milk-thistle fruit published in the European Pharmacopoeia (Ph.Eur. 9th Edition; Ref.
01/2014:1860): Mature fruit, devoid of the pappus, of Silybum marianum L. Gaertn.
(Asteraceae). Content: minimum 1.5% of silymarin, expressed as silibinin (C25H22O10; MT
482.4) (dried drug)
- Cardui mariae (or mariani) fructus (BHP 1996): Dried ripe fruits of Silybum marianum (L.)
Gaertn. (No chemical composition or minimum content is included)
- Cardo mariano, fruto de (Spanish Pharmacopoeia, 5th Edition 2015; Ref 01/2008, 1860).
Gastrointestinal disorders Traditional use
Traditional herbal medicinal product for the
symptomatic relief of digestive disorders,
sensation of fullness and indigestion and to
support the liver function, 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.
https://www.ema.europa.eu/en/medicines/herbal/silybi-mariani-fructus
Zingiberis rhizoma Zingiber officinale Roscoe Ginger Ginger (Zingiberis rhizoma) consists of the whole or cut rhizome of Zingiber officinale Roscoe (Zingiberaceae), with the cork removed, either completely or from the wide, flat surfaces only [European Pharmacopoeia 2011]. Gastrointestinal disorders Well-established use:Herbal medicinal product for the prevention of
nausea and vomiting in motion sickness. Traditional use: Indication 1)
Traditional herbal medicinal product for the
symptomatic relief of motion sickness.
Indication 2)
Traditional herbal medicinal product for
https://www.ema.europa.eu/en/medicines/herbal/zingiberis-rhizoma
Combination: Species amarae Herbal tea combinations for use in loss of appetite This assessment report refers to herbal tea combinations used in the therapeutic area �loss of appetite�.
Herbal substances contained in such combinations for which an assessment by the HMPC has been
performed are Millefolii herba, Absinthii herba, Centaurii herba, Cichorii radix, Gentianae radix,
Menyanthidis folium, Marrubii herba and Taraxaci radix cum herba
.
Loss of appetite Traditional herbal medicinal product used for temporary loss of appetite. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. https://www.ema.europa.eu/en/medicines/herbal/combination-species-amarae
Marrubii herba Marrubium vulgare L. White horehound �Whole or fragmented dried flowering aerial plants of Marrubium vulgare L. Content: minimum
0.7% marrubiin (C20H20O4; M: 332.4) (dried drug).�
Loss of appetite, Cough and cold, Gastrointestinal disorders With regard to the registration application of
Article 16d(1) of Directive 2001/83/EC as
amended
Marrubium vulgare L., herba (White Horehound)
i) Herbal substance
Not applicable.
ii) Herbal preparations
a) Comminuted herbal substance
b) Powdered herbal substance
c) Expressed juice (DER 1:0.70-0.90)
d) Liquid extract (DER 1:0.9-1.1), extraction
solvent ethanol 20-30% V/V
https://www.ema.europa.eu/en/medicines/herbal/marrubii-herba
Absinthii herba Artemisia absinthium L. Wormwood Basal leaves or slightly leafy, flowering tops, or mixture of these dried, whole or cut organs of
Artemisia absinthium L. Content: minimum 2 ml/kg of essential oil (dried drug); bitterness value:
minimum 10,000.
Loss of appetite, Gastrointestinal disorders Indication 1)
Traditional herbal medicinal product for
temporary loss of appetite.
Indication 2)
Traditional herbal medicinal product for mild
dyspeptic/gastrointestinal disorders.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
https://www.ema.europa.eu/en/medicines/herbal/absinthii-herba
Centaurii herba Centaurium erythraea Rafn. s.l. Centaury Centaurii herba consists of the whole 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.) (Ph. Eur., 2008).
Loss of appetite, Gastrointestinal disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/centaurii-herba
Cichorii intybi radix Cichorium intybus L. Chicory root Cichorium intybus is a member of the Asteraceae family. The genus Cichorium consists of six species
with major distribution areas in Europe and Asia. Member of the species are cultivated in Europe for
salad leaves, chicons (blanched buds), or for roots (var. sativum), which are baked, ground, and used
as a coffee substitute and additive.
Loss of appetite, Gastrointestinal disorders 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.
The product is a traditional herbal medicinal
product for use in the specified indication
https://www.ema.europa.eu/en/medicines/herbal/cichorii-intybi-radix
Lichen islandicus Cetraria islandica (L.) Acharius s.l. Iceland moss The thallus, up to 15 cm long, is irregularly dichotomous and consists of glabrous, groove-shaped or
almost flat, stiff, brittle bands, 0.3-1.5 cm wide and about 0.5 mm thick, sometimes serrated with the
margin appearing ciliated (pycnidia). The upper surface is greenish or greenish-brown, the lower
surface is greyish-white or light brownish and shows whitish, depressed spots (so-called respiratory
cavities). On the apices of the terminal lobes, very rarely, there are brown, discoid apothecia.
Loss of appetite, Mouth and throat disorders, Cough and cold 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.
https://www.ema.europa.eu/en/medicines/herbal/lichen-islandicus
Harpagophyti radix Harpagophytum procumbens DC.; Harpagophytum zeyheri Decne Devil�s Claw Root The herbal substance consists of cut and dried, tuberous secondary root of two species of
Harpagophytum (Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne.). It contains
not less than 1.2% of harpagoside, calculated with reference to the dried drug (European
Pharmacopoeia, Harpagophyti radix, monograph 01/2011:1095).
Loss of appetite, Pain and inflammation, Gastrointestinal disorders Indication 1)
Traditional herbal medicinal product for relief of
minor articular pain.
Indication 2)
Traditional herbal medicinal product used for the
relief of mild digestive disorders such as bloating
and flatulence and where there is temporary loss
of appetite.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use
https://www.ema.europa.eu/en/medicines/herbal/harpagophyti-radix
Menyanthidis trifoliatae folium Menyanthes trifoliata L. Bogbean leaf Bogbean leaf, (Eur Pharmacopoeia No:1605, Menyanthidis trifoliatae folium) consists of dried, entire or
fragmented leaves of Menyanthes trifoliata L. with very bitter and persistent taste (required bitterness
value min. 3000) and showing a presence of loganin in thin layer chromatography.
Loss of appetite, Pain and inflammation, Gastrointestinal disorders Indication 1)
Traditional herbal medicinal product used in
temporary loss of appetite.
Indication 2)
Traditional herbal medicinal product used for the
relief of mild digestive disorders such as bloating
and flatulence.
Indication 3)
Traditional herbal medicinal product used for relief
of minor articular and muscular pain.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
https://www.ema.europa.eu/en/medicines/herbal/menyanthidis-trifoliatae-folium
Trigonellae foenugraeci semen Trigonella foenum-graecum�L. Fenugreek Fenugreek seed is rich in mucilage polysaccharide (consisting mainly in galactomannans 25�45%) and
contains a small amount of essential oil (0.015%) and a variety of secondary metabolites, including
protoalkaloids, trigonelline (up to 0.37%), choline (0.05%); saponins (0.6�1.7%) derived from
diosgenin, yamogenin, tigogenin and other compounds; sterols including ?-sitosterol; and flavonoids,
among which are orientin, isoorientin and isovitexin (WHO, 2007). Furthermore, the nutrition
composition of fenugreek seeds is : moisture 2.4 %, protein 30 %, lipids 7 %, saponins 4.8 %, total
dietetary fibre 48.% (insoluble 28.%, soluble 20.%), and ash 3.9 % (WHO, 2003; ESCOP 2003;
MURALIDHARA et al, 1999; BRUNETON 1998; RAO et al, 1996; PARIS AND MOYSE, 1967.
Loss of appetite, Skin disorders and minor wounds 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. https://www.ema.europa.eu/en/medicines/herbal/trigonellae-foenugraeci-semen
Arctii radix Arctium lappa L. Burdock Root Arctium lappa L. is a biennial member of the Compositae (Asteraceae) that can reach one meter and a
half. It has large cordiform leaves. The purple flowers appear from July until September. The spherical
flower head, three to four centimeters in diameter, has rough hairs (Delfosse 1998, Lambinon 1998).
Native in Europe, Northern Asia and North America (Wichtl 1994).
Loss of appetite, Skin disorders and minor wounds, Urinary tract and genital disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/arctii-radix
Millefolii flos Achillea millefolium�L. Yarrow Flower The essential oil contains numerous identified components including borneol, bornyl acetate (trace),
camphor, 1.8-cineole, eucalyptol, limonene, sabine, terpin-4-ol, terpineol and ?-thujone
(monoterpenes), caryophyllene (a sesquiterpene) achillicin, achillin, millefin and millefolide
(sesquiterpene lactones), azulene and chamazulene (sesquiterpene lactone derived), and isoartemisia
ketone. The relative composition of components varies greatly between Achillea species, especially the
azulene content. Azulene has been reported as the major component. However, true yarrow (A.
millefolium) is thought to be hexaploid and azulene-free, whereas closely related species, such as
Achillea lanulosa Nutt. and Achillea collina Becker, are tetraploid and contain up to 50% azulene in
their volatile oil. It is possible that the tetraploid species may be supplied for A. millefolium (Barnes et
al. 2007).
Loss of appetite, Skin disorders and minor wounds, Urinary tract and genital disorders, Gastrointestinal disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/millefolii-flos
Millefolii herba Achillea millefolium L. Yarrow According to the definition in the European Pharmacopoeia 9th ed. (2016), the herbal substance is the
whole or cut, dried flowering tops of yarrow, Achillea millefolium L., and it should contain a minimum
of 2 ml/kg essential oil (dried drug) and proazulenes, expressed as chamazulene (C14H16; Mr 184.3) a
minimum of 0.02 percent (dried drug) (Ph. Eur. monograph ref.: 2016:1564-5).
Loss of appetite, Skin disorders and minor wounds, Urinary tract and genital disorders, Gastrointestinal disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/millefolii-herba
Lupuli flos Humulus lupulus L. Hop strobile Bitter principles consisting mainly of prenylated phloroglucinol derivatives known as alfa-acids or
humulones (2-12% of dried strobile), principally humulone (35-70%), and beta-acids or lupulones (1-
10% of dried strobile), principally lupulone (30-55%) (Verzele, 1986, De Keukeleire et al., 1999,
Wohlfart et al., 1993, H�lz, 1992, H�nsel and Schultz, 1986).
Loss of appetite, Sleep disorders and temporary insomnia, Mental stress and mood disorders 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 https://www.ema.europa.eu/en/medicines/herbal/lupuli-flos
Taraxaci officinalis radix Taraxacum officinale F.H. Wigg. Dandelion root NO DATA Loss of appetite, Urinary tract and genital disorders, Gastrointestinal disorders NO DATA https://www.ema.europa.eu/en/medicines/herbal/taraxaci-officinalis-radix
Taraxaci radix cum herba Taraxacum officinale Weber ex Wigg. Dandelion Root with Herb NO DATA Loss of appetite, Urinary tract and genital disorders, Gastrointestinal disorders NO DATA https://www.ema.europa.eu/en/medicines/herbal/taraxaci-radix-cum-herba
Caryophylii floris aetheroleum Syzygium aromaticum�(L.) Merill et L.�M. Perry Clove oil Mouth and throat disorders https://www.ema.europa.eu/en/medicines/herbal/caryophylii-floris-aetheroleum
Verbasci flos Verbascum thapsus L.; V. densiflorum Bertol. (V. thapsiforme Schrad); V. phlomoides L. Mullein Flower Mouth and throat disorders, Cough and cold https://www.ema.europa.eu/en/medicines/herbal/verbasci-flos
Althaeae radix Althaea officinalis L. Marshmallow Root Mouth and throat disorders, Cough and cold, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/althaeae-radix
Myrtilli fructus siccus Vaccinium myrtillus L. Dried Bilberry fruit Mouth and throat disorders, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/myrtilli-fructus-siccus
Tormentillae rhizoma Potentilla erecta (L.) Raeusch. Tormentil Mouth and throat disorders, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/tormentillae-rhizoma
Rubi idaei folium Rubus idaeus L. Raspberry leaf Mouth and throat disorders, Pain and inflammation, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/rubi-idaei-folium
Calendulae flos Calendula officinalis L. Calendula Flower Whole or cut, dried, fully opened flowers, which have been detached from the receptacle, of the
cultivated, double-flowered varieties of Calendula officinalis L. It contains not less than 0.4% of
flavonoids, calculated as hyperoside (C21H20O12, Mr 464.4) with reference to the dried herbal
substance.
Mouth and throat disorders, Skin disorders and minor wounds Indication 1)
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 2)
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 the specified indication exclusively based upon
long-standing use.
https://www.ema.europa.eu/en/medicines/herbal/calendulae-flos
Melaleucae aetheroleum Melaleuca alternifolia (Maiden and Betche) Cheel Tea-tree oil Mouth and throat disorders, Skin disorders and minor wounds https://www.ema.europa.eu/en/medicines/herbal/melaleucae-aetheroleum
Myrrha, gummi-resina Mouth and throat disorders, Skin disorders and minor wounds https://www.ema.europa.eu/en/medicines/herbal/myrrha-gummi-resina
Rosae flos Rosa centifolia L.; Rosa gallica L.; Rosa damascena Mill. Rose flower Mouth and throat disorders, Skin disorders and minor wounds https://www.ema.europa.eu/en/medicines/herbal/rosae-flos
Matricariae flos Matricaria recutita L. Matricaria Flower Mouth and throat disorders, Skin disorders and minor wounds, Cough and cold, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/matricariae-flos
Agrimoniae herba Agrimonia eupatoria L. Agrimony Dried flowering topsof Agrimonia eupatoriaL Mouth and throat disorders, Skin disorders and minor wounds, Gastrointestinal disorders Indication 1)Traditional herbal medicinal product for the symptomatic treatment of mild diarrhoea.Indication 2)Traditional herbal medicinal product for useas 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 inflammationand small, superficial wounds.The product is a traditional herbal medicinal product for use in the specifiedindicationsexclusively based upon long-standing use https://www.ema.europa.eu/en/medicines/herbal/agrimoniae-herba
Salviae officinalis folium Salvia officinalis L. Sage Leaf Mouth and throat disorders, Skin disorders and minor wounds, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/salviae-officinalis-folium
Polygoni avicularis herba Polygonum aviculare L. Knotgrass herb Mouth and throat disorders, Urinary tract and genital disorders, Cough and cold https://www.ema.europa.eu/en/medicines/herbal/polygoni-avicularis-herba
Arnicae flos Arnica montana L. Arnica flower Pain and inflammation https://www.ema.europa.eu/en/medicines/herbal/arnicae-flos
Capsici fructus Capsicum annuum L. var. minimum (Miller) Heiser Capsicum Dried ripe fruits of Capsicum annuum L. var. minimum (Miller) Heiser and small-fruited varieties of
Capsicum frutescens L. (Capsici fructus)
Content: minimum 0.4% of total capsaicinoids, expressed as capsaicin (C18H27NO3; Mr 305.4)
(dried drug).
Constituents (Blaschek et al. 2012):
Capsaicinoids: 0.3 � more than 1% of total capsaicinoids, consisting of 63-77% capsaicin, 20-32%
dihydrocapsaicin, 1-8% nordihydrocapsaicin, and undefined amounts of homodihydrocapsaicin I and II,
vanillylamides of caprylic acid and nonylic acid.
Other constituents: fatty oil, carotenoids, ascorbic acid, volatile compounds.
Pain and inflammation Herbal medicinal product for the relief of muscle
pain such as low back pain.
https://www.ema.europa.eu/en/medicines/herbal/capsici-fructus
Salviae miltiorrhizae rhizoma Salvia miltiorrhiza Bunge Salvia miltiorrhiza root and rhizome Pain and inflammation https://www.ema.europa.eu/en/medicines/herbal/salviae-miltiorrhizae-rhizoma
Symphyti radix Symphytum officinale L. Comfrey Root Pain and inflammation https://www.ema.europa.eu/en/medicines/herbal/symphyti-radix
Tanaceti parthenii herba Tanacetum parthenium (L.) Schultz Bip. Feverfew Pain and inflammation https://www.ema.europa.eu/en/medicines/herbal/tanaceti-parthenii-herba
Eucalypti aetheroleum Eucalyptus globulus Labill.; Eucalyptus polybractea�R.T.�Baker; Eucalyptus smithii�R.T.�Baker. Eucalyptus Oil Pain and inflammation, Cough and cold https://www.ema.europa.eu/en/medicines/herbal/eucalypti-aetheroleum
Filipendulae ulmariae flos Filipendula ulmaria�(L.) Maxim. (= Spiraea ulmaria�L.). Meadowsweet Flower Pain and inflammation, Cough and cold https://www.ema.europa.eu/en/medicines/herbal/filipendulae-ulmariae-flos
Filipendulae ulmariae herba Filipendula ulmaria�(L.) Maxim. (= Spiraea ulmaria�L.). Meadowsweet Pain and inflammation, Cough and cold https://www.ema.europa.eu/en/medicines/herbal/filipendulae-ulmariae-herba
Salicis cortex Salix [various species including S. purpurea L.; S. daphnoides Vill.; S. fragilis L.] Willow Bark Pain and inflammation, Cough and cold https://www.ema.europa.eu/en/medicines/herbal/salicis-cortex
Pistacia lentiscus, resinum (mastic) Pain and inflammation, Skin disorders and minor wounds https://www.ema.europa.eu/en/medicines/herbal/pistacia-lentiscus-resinum-mastic
Menthae piperitae folium Mentha x piperita L. peppermint leaf Pain and inflammation, Skin disorders and minor wounds, Cough and cold, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/menthae-piperitae-folium
Urticae herba Urtica dioica L.; Urtica urens L. Nettle Herb Pain and inflammation, Skin disorders and minor wounds, Urinary tract and genital disorders https://www.ema.europa.eu/en/medicines/herbal/urticae-herba
Ribis nigri folium Ribes nigrum L. Blackcurrant Leaf Pain and inflammation, Urinary tract and genital disorders https://www.ema.europa.eu/en/medicines/herbal/ribis-nigri-folium
Juniperi aetheroleum Juniperus communis L. Juniper Oil Pain and inflammation, Urinary tract and genital disorders, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/juniperi-aetheroleum
Avenae fructus Avena sativa L. Oat Fruit The fatty oil is obtained from seeds of Oenothera biennis L. or Oenothera lamarckiana L. by extraction
and/or expression. It contains 65-85% linoleic acid, 7-14% gamma-linolenic acid (?-linolenic acid) and
a maximum of 0.5% is alpha-linolenic acid. Other substances are 5-12% oleic acid, 1-4% stearic acid,
4-10% palmitic acid and a maximum of 0.3% saturated fatty acids of chain length less than C16
(European Pharmacopoeia, 2010).
Skin disorders and minor wounds Herbal preparation in solid dosage forms for oral
use.
The pharmaceutical form should be described by
the European Pharmacopoeia full standard term.
https://www.ema.europa.eu/en/medicines/herbal/avenae-fructus
Juglandis folium Juglans regia L. Walnut leaf Matricaria liquid extract, Matricariae extractum fluidum, monograph (Ph. Eur. 01/2008: 1544)
Liquid extract produced from Matricaria flower (Ph. Eur. 01/2008:0404)
Content: minimum 0.30% of blue residual oil
The extract is produced using a mixture of 2.5 volumes of a 10% (m/m) solution of ammonia (NH3),
47.5 volumes of water and 50 volumes of ethanol (96%(V/V)).
Skin disorders and minor wounds Traditional herbal medicinal product used for
adjuvant therapy of irritations of skin and
mucosae in the anal and genital region, after
serious conditions have been excluded by a
medical doctor.
The product is a traditional herbal medicinal
https://www.ema.europa.eu/en/medicines/herbal/juglandis-folium
Matricariae aetheroleum Matricaria recutita L. Matricaria Oil The plant is used for its fruits and also herb, harvested before flowering (H�nsel et al. 1992). In
addition, some authors refer to use of the fresh plant just before harvest (Anand 1971; Bye et al. 1974).
Skin disorders and minor wounds 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.
https://www.ema.europa.eu/en/medicines/herbal/matricariae-aetheroleum
Oenotherae biennis oleum Oenothera biennis L.; Oenothera lamarckiana L. Evening Primrose Oil Soya-bean oil, refined, is fatty oil obtained from seeds of Glycine max (L). Merr. by extraction and
subsequent refining in accordance with the European Pharmacopoeia (01/2010:1473). Soya bean is an
annual herbaceous plant in the family Fabaceae (legume or bean family) that is cultivated. The fruit
contains 1�4 ovoid to spherical seeds of variable colour (Bruneton, 1999). The major fatty acids are
linoleic acid (48�58%), oleic acid (17�30%), palmitic acid (9�13%), linolenic acid (5�11%) and stearic
acid (2.5�5%). Soya-bean oil, refined, also contains myristic acid (maximum 0.2%), palmitoleic acid
(maximum 0.3%), arachidic acid (maximum 1.0%), eicosenoic acid (maximum 1.0%) and behenic acid
(maximum 1.0%) (European Pharmacopoeia 01/2010:1473).
Skin disorders and minor wounds Traditional herbal medicinal product used for the
symptomatic relief of dry skin conditions
associated with mild recurrent eczema.
The product is a traditional herbal medicinal
product for use in the specified indication
https://www.ema.europa.eu/en/medicines/herbal/oenotherae-biennis-oleum
Soiae oleum raffinatum refined Soya-bean oil The herbal substance is described as the dried entire � margined leaflets freed from the rachis with
faintly aromatic odour and astringent, somewhat bitter and harsh taste (Wichtl, 2004). By long
preservation the leaves become brown and lose their aroma. Juglans regia leaves contain
approximately 10% tannins (elegitannins) while juglone is unstable and in dry leaves it is present only
in traces. According to the French Pharmacopoeia (10th Ed.) Juglandis folium contains not less than 2% of total flavonoids (Bruneton 1995, Ph. Fr. X)
Skin disorders and minor wounds 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.
https://www.ema.europa.eu/en/medicines/herbal/soiae-oleum-raffinatum
Solani dulcamarae stipites Solanum dulcamara L. Woody nightshade stem 3 g of the comminuted herbal substance/250 ml of water.
Dry extract: dry extract (6:1), extraction solvent: water.
Skin disorders and minor wounds 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.
https://www.ema.europa.eu/en/medicines/herbal/solani-dulcamarae-stipites
Violae tricoloris herba cum flore Viola tricolor L. and/or subspecies Viola arvensis Murray (Gaud); Viola vulgaris Koch (Oborny) Wild Pansy consists of the dried 2- to 3-year-old stems of the plant, harvested in
spring prior to leafing or in the late autumn after leaves have dropped (Blumenthal et al., 1998).
Skin disorders and minor wounds Traditional herbal medicinal product for the
symptomatic relief of mild recurrent eczema.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
https://www.ema.europa.eu/en/medicines/herbal/violae-tricoloris-herba-cum-flore
Hamamelidis cortex Hamamelis virginiana L. Hamamelis Bark �Hamamelidis folium� consists of the dried or fresh leaves of Hamamelis virginiana L. It contains not less than 3% of tannins, expressed as pyrogallol (C6H6O3; Mr 126.1) and calculated with reference to the dried drug. The material complies with the monograph of the European Pharmacopoeia 6.1, [monograph (04/2008:0909)]. Leaves are about 7 to 15 cm long, brittle, dark green or brownish-green, alternate, stipulate, broadly oval or rhomboid ovate; short-petiolated about 1 to 1.5 cm long, margin coarsely crenate or sinuate, apex acute or rounded, base cordate and unequal and venation pinnate, lateral veins straight, Skin disorders and minor wounds, Circulatory disorders 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. https://www.ema.europa.eu/en/medicines/herbal/hamamelidis-cortex
Hamamelidis folium Hamamelis virginiana L. Hamamelis Leaf Hamamelis virginiana L. (synonym: witch hazel) is a plant of the Hamamelidaceae family. It is a deciduous, tall shrub, or small tree, branches highly branched, indigenous to the Atlantic coast of North America, found in damp woods ranging from Nova Scotia to Florida and as far west as Texas. It is cultivated on a small scale in Europe, though the material of commerce is obtained mainly from the eastern USA and Canada (Wichtl and Bisset, 1994). Skin disorders and minor wounds, Circulatory disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/hamamelidis-folium
Meliloti herba Melilotus officinalis (L.) Lam. Melilot The European
Pharmacopoea requires of herbal substance min 0.3% of coumarin. The main coumarin derivative
contained in dried melilot herb is melilotoside, o-glycosid of coumaric acid, which is present in dry
melilot herb in a quantity of 0.4% (Bradley, 2006) up to 6% (HagerROM, 2014).
Skin disorders and minor wounds, Circulatory disorders Traditional herbal medicinal product used for the 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. https://www.ema.europa.eu/en/medicines/herbal/meliloti-herba
Quercus cortex Quercus robur L.; Quercus petraea (Matt.) Liebl.; Quercus pubescens Willd. Oak Bark In the European Pharmacopoeia, it is described as the cut and dried bark of young branches and the
lateral shoots of Quercus robur, Quercus petraea and/or Quercus pubescens. It contains a minimal
amount of 3% of tannins, expressed as pyrogallol, calculated with reference to the dried herbal
Substance.
Skin disorders and minor wounds, Circulatory disorders, Gastrointestinal disorders traditional herbal medicinal product for
nt of minor inflammation of
symptomatic treatme
the oral mucosa or skin
https://www.ema.europa.eu/en/medicines/herbal/quercus-cortex
Echinaceae purpureae herba Echinacea purpurea (L.) Moench Purple Coneflower Herb The US Pharmacopeia contains the monograph �Echinacea purpurea Aerial Parts�, which defines the drug as: �consists of the aerial parts of Echinacea purpurea (L.) Moench (Fam. Asteraceae). It is harvested during the flowering stage. It contains not less than 1.0 percent of chichoric acid, and not less than 0.01 percent of dodecatetraenoic acid isobutylamides (C16H25NO) on the dry basis� (Giancaspro 2004). Skin disorders and minor wounds, Cough and cold With regard to the marketing authorisation application of Article 10(a) of Directive 2001/83/EC as amended Echinacea purpurea (L.) Moench, herba recens (purple coneflower herb) i) Herbal substance Not applicable ii) Herbal preparations - expressed juice (DER 1.5-2.5:1) - dried juice corresponding to the expressed juice above https://www.ema.europa.eu/en/medicines/herbal/echinaceae-purpureae-herba
Echinaceae purpureae radix Echinacea purpurea (L.) Moench. Purple Coneflower Root ? Alkamides (0.01-0.7%): mainly isobutylamides of straight-chain fatty-acids with olefinic and/or acetylenic bonds e.g. isomeric dodeca-2E,4E,8Z,10E/Z-tetraenoic isobutylamide. Undeca-2Z,4Ediene-8,10-diynoic acid isobutylamide is also prominent. Isobutylamides contain mainly 2,4- dienoic units. ? Caffeic acid derivatives (2.0-2.8%): principally cichoric acid (2,3-O-dicaffeoyltartaric acid, 1.7- 2.4%) and caftaric acid (2-O-caffeoyltartaric acid, ca. 0.2-0.8%) also echinacoside, verbascoside, caffeoylechinacoside, chlorogenic and isochlorogenic acids. ? Polysaccharides and glycoproteins: arabinogalactans, and an arabinogalactan-containing glycoprotein with a sugar component consisting of arabinose (64-84%), galactose (2-5%) and galactosamine (6%). ? Volatile oil (0.1%): caryophyllene, caryophyllene oxide, humulene, ?-phellandrene, limonene, camphene, aldehydes and dimethyl sulphide. Skin disorders and minor wounds, Cough and cold With regard to the registration application of Article 16d(1) of Directive 2001/83/EC Echinacea purpurea (L.) Moench, radix (purple coneflower root) i) Herbal substance Not applicable ii) Herbal preparations a) Dry extract (DER 5.5-7.5:1), extraction solvent ethanol 45% (V/V) b) Dry extract (DER 4:1); extraction solvent water https://www.ema.europa.eu/en/medicines/herbal/echinaceae-purpureae-radix
Origani dictamni herba Origanum dictamnus L. Dittany of Crete herb Additionally a recent ethnopharmacological study, considering the herbs traded in the local markets of Thessaloniki, reported the following therapeutic uses for the aerial parts of the herb applied either as an infusion for oral use or as an external application (cutaneous use as compress or washing): Gastrointestinal disorders - spasmolytic, stomach ulcer, Skin disorders - antiseptic, antibacterial activities, aphrodisiac (Hanlidou et al. 2004). Skin disorders and minor wounds, Cough and cold, Gastrointestinal disorders Traditional herbal medicinal product used for the
relief of minor skin inflammations and bruises.
https://www.ema.europa.eu/en/medicines/herbal/origani-dictamni-herba
Hamamelidis folium et cortex aut ramunculus destillatum Hamamelis virginiana L. Hamamelis Distillate �Hamamelidis cortex� consists of the dried bark from the stems, branches and twigs of Hamamelis
virginiana L. (Fam. Hamamelidaceae), collected in spring. It contains not less than 4.0% of hide-powder
precipitable tannins, expressed as pyrogallol (C6H6O3; Mr 126.1) and calculated with reference to the
dried drug
Skin disorders and minor wounds, Eye discomfort Traditional herbal medicinal product for
relief of minor skin inflammation and
dryness of the skin.
https://www.ema.europa.eu/en/medicines/herbal/hamamelidis-folium-et-cortex-aut-ramunculus-destillatum
Origani majoranae herba Origanum majorana L. Majoram An ethnopharmacological study in two Italian villages (guided interviews and survey, 328 people aged from 60 to 80 years) evidenced the traditional use of the infusion of O. majorana leaves for treatment of stomach pain, neuralgia and as sedative (Loi et al., 2005). Skin disorders and minor wounds, Gastrointestinal disorders Traditional herbal medicinal product used for
relief of irritated skin around the nostrils.
https://www.ema.europa.eu/en/medicines/herbal/origani-majoranae-herba
Hyperici herba Hypericum perforatum L. St. John's Wort Hyperici herba consists of the whole or cut, dried flowering tops of Hypericum perforatum L.,
harvested during flowering time. It contains not less than 0.08% of total hypericins expressed as
hyericin calculated with reference to the dried drug.
Skin disorders and minor wounds, Mental stress and mood disorders, Gastrointestinal disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/hyperici-herba
Aloysiae folium Aloysia citriodora Pal�u (syn. Aloysia triphylla (L�H�r.) Kuntze; Verbena triphylla � Lemon verbena leaf no nos enteramos de nada, concuerdo :( Sleep disorders and temporary insomnia, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/aloysiae-folium
Avenae herba Avena sativa L. Oat Herb Sleep disorders and temporary insomnia, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/avenae-herba
Combination: Species digestivae/stomachicae Herbal tea combinations for use in gastrointestinal complaints Sleep disorders and temporary insomnia, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/combination-species-digestivaestomachicae
Combination: Valerianae radix and Lupuli flos Combination: Valeriana officinalis L. and Humulus lupulus L. Valerian Root and Hop Strobile Sleep disorders and temporary insomnia, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/combination-valerianae-radix-lupuli-flos
Eschscholziae herba Eschscholzia california Cham. California poppy Sleep disorders and temporary insomnia, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/eschscholziae-herba
Lavandulae aetheroleum Lavandula angustifolia Mill. (L. officinalis Chaix) Lavender Oil Lavender flower contains not less than 13 ml/kg of essential oil, calculated with reference to the dried
drug.
Sleep disorders and temporary insomnia, Mental stress and mood disorders 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.
https://www.ema.europa.eu/en/medicines/herbal/lavandulae-aetheroleum
Lavandulae flos Lavandula angustifolia Mill. (L. officinalis Chaix) Lavender Lavender flower contains not less than 13 ml/kg of essential oil, calculated with reference to the dried
drug.
Sleep disorders and temporary insomnia, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/lavandulae-flos
Passiflorae herba Passiflora incarnata L. Passion Flower Sleep disorders and temporary insomnia, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/passiflorae-herba
Valerianae aetheroleum Valeriana officinalis Valerian essential oil Sleep disorders and temporary insomnia, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/valerianae-aetheroleum
Valerianae radix Valeriana officinalis L. Valerian Root Sleep disorders and temporary insomnia, Mental stress and mood disorders https://www.ema.europa.eu/en/medicines/herbal/valerianae-radix
Melissae folium Melissa officinalis L. Melissa leaf Sleep disorders and temporary insomnia, Mental stress and mood disorders, Gastrointestinal disorders https://www.ema.europa.eu/en/medicines/herbal/melissae-folium
Agni casti fructus Vitex agnus-castus L. Agnus Castus Fruit Whole, ripe, dried fruit of Vitex agnus-castus L. Content: minimum 0.08% of casticin (C19H18O8; Mr 374.3) (dried drug) Urinary tract and genital disorders Herbal medicinal product for the treatment of premenstrual syndrome https://www.ema.europa.eu/en/medicines/herbal/agni-casti-fructus
Agropyri repentis rhizoma Couch grass rhizome ouch grass rhizome (Graminis rhizoma) is defined as the whole or cut, washed and dried rhizome of Agropyron repens (L.) Beauv. (Elymus repens (L.) Gould); the adventitious roots are removed Urinary tract and genital disorders 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. https://www.ema.europa.eu/en/medicines/herbal/agropyri-repentis-rhizoma
Betulae folium Betula pendula Roth / Betula pubescens Ehrh. Birch Leaf Whole or fragmented dried leaves of Betula pendula Roth and/or Betula pubescens Ehrh. as well as hybrids of both species. They contain no less than 1.5% of flavonoids, expressed as hyperoside (C21H20O12 = 464.4), with reference to the dried drug Urinary tract and genital disorders 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. https://www.ema.europa.eu/en/medicines/herbal/betulae-folium
Bursae pastoris herba Capsella bursa-pastoris (L.) Medikus Shepherds Purse A benzene extract of the aerial parts of Capsella bursa-pastoris was fractionated into seven fractions: polar lipids (34.7%), free fatty acids, triterpenols (25.8%), diacylglycerols, waxy esters (12.8%), sterols, chlorophylls (12.4%), triacylglycerols (6.7%), unidentified compounds (4.1%) and hydrocarbons (3.5%) Urinary tract and genital disorders Traditional herbal medicinal product for the reduction of heavy menstrual bleeding in women with regular menstrual cycles, after serious https://www.ema.europa.eu/en/medicines/herbal/bursae-pastoris-herba
Cimicifugae rhizoma Cimicifuga racemosa (L.) Nutt. Black Cohosh a) Dry extract from CR (DER 5-10:1); extraction solvent ethanol 58% (V/V) b) Dry extract from CR (DER 4.5-8.5:1); extraction solvent ethanol 60% (V/V) c) Dry extract from CR (DER 6-11:1); extraction solvent propan-2-ol 40% (V/V) Urinary tract and genital disorders Herbal medicinal product for the relief of menopausal complaints such as hot flushes and profuse sweating. https://www.ema.europa.eu/en/medicines/herbal/cimicifugae-rhizoma
Combination: Species diureticae Combination: maximum 4 out of 13 possible plants Diuretic herbal tea combinations e Betulae folium, Equiseti herba, Graminis rhizoma (Agropyri repentis rhizoma), Juniperi galbulus (Juniperi pseudo-fructus), Levistici radix, Mate folium, Ononidis radix, Orthosiphonis folium, Phaseoli fructus, Polygoni avicularis herba, Solidaginis virgaureae herba, Urticae folium, Urticae herba and Uvae ursi folium Urinary tract and genital disorders 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 https://www.ema.europa.eu/en/medicines/herbal/combination-species-diureticae
Cucurbitae semen Cucurbita pepo L. Pumpkin seed The herbal substance consists of the whole, ripe and dried seeds. Urinary tract and genital disorders Traditional herbal medicinal product for the relief of lower urinary tract symptoms related to benign https://www.ema.europa.eu/en/medicines/herbal/cucurbitae-semen
Epilobii herba Epilobium angustifolium L. and/or Epilobium parviflorum Schreb. Willow herb ). It includes the dried flowering herb of Epilobium parviflorum Schreb., Epilobium montanum L., Epilobium collinum C. C. Gmel. and Epilobium roseum Schreb. The herbal substance contains not less than 8% of tannins Urinary tract and genital disorders 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 https://www.ema.europa.eu/en/medicines/herbal/epilobii-herba
Equiseti herba Equisetum arvense L. Horsetail herb Equiseti herba is the whole or cut, dried sterile aerials parts of Equisetum arvense L. Content: minimum 0.3% of total flavonoids, expressed as isoquercitroside Urinary tract and genital disorders 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 complaints. Indication 2 Traditional herbal medicinal product used for supportive treatment of superficial wounds. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use https://www.ema.europa.eu/en/medicines/herbal/equiseti-herba
Herniariae herba Herniariae glabra L.; Herniariae hirsuta L.; Herniariae incana LAM., herba Rupturewort Betulae folium, Equiseti herba, Graminis rhizoma (Agropyri repentis rhizoma), Juniperi galbulus (Juniperi pseudo-fructus), Levistici radix, Mate folium, Ononidis radix, Orthosiphonis folium, Phaseoli fructus, Polygoni avicularis herba, Solidaginis virgaureae herba, Urticae folium, Urticae herba and Uvae ursi folium. Urinary tract and genital disorders 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 https://www.ema.europa.eu/en/medicines/herbal/herniariae-herba
Juniperi pseudo-fructus Juniperus communis L. Juniper berry Monoterpenes (about 58% of the essential oil); the essential oil contains mainly ?-pinene (20%), limonene (8.7%), myrcene (8.5%) and ?-pinene, myrcene, sabinene, 1,4-cineol, camphene, ?�-carene, terpinen-4-ol, terpinolene, 4-terpineol, ?-elemene-7-ol Urinary tract and genital disorders 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. https://www.ema.europa.eu/en/medicines/herbal/juniperi-pseudo-fructus
Levistici radix Levisticum officinale Koch. Lovage root lovage root essential oil: ?-pinen (4.5-4.6%), camphene (1.0-1.1%), ?-pinene (7.1-8.0%), myrcene (0.9%), ?-phellandrene 0.4-0.5%), ?-terpinene (0.1%), limonene (0.8-1,2%), ?-phellandrene (8.7-10.7%), cis-ocimene (0.2-0.4%), ?terpinene/trans-ocimene (0.2-0.3%), terpinolene (1.2-1.5%), pentylcyclohexadiene (7.4-12.7%), pentylbenzene (0.1-0.3%), 3n-butytlidenephtalide (31.5-32.0%) and 3n-butylidene-4,5- dihydrophtalide (23.5-24.9%) Urinary tract and genital disorders 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. https://www.ema.europa.eu/en/medicines/herbal/levistici-radix
Oleae folium Olea europaea L. Olive leaf The fatty oil is obtained from seeds of Oenothera biennis L. or Oenothera lamarckiana L. by extraction and/or expression. It contains 65-85% linoleic acid, 7-14% gamma-linolenic acid (?-linolenic acid) and a maximum of 0.5% is alpha-linolenic acid. Other substances are 5-12% oleic acid, 1-4% stearic acid, 4-10% palmitic acid and a maximum of 0.3% saturated fatty acids of chain length less than C16 (European Pharmacopoeia, 2010). Urinary tract and genital disorders product for use in specified indication exclusively based upon long-standing use. https://www.ema.europa.eu/en/medicines/herbal/oleae-folium
Ononidis radix Ononis spinosa L. Restharrow root Restharrow root is more or less flattened, twisted and bent with a greyish brown to dark brown outer surface and deep longitudinal grooves. Characteristic of the transversely cut surface is the conspicuously radiate structure of the xylem due to the unequal width of the medullary rays. The fracture of the root is short and fibrous. It has bitter taste resembling that of liquorice and is regarded as an aperitif, diuretic, anti-inflammatory and astringent [Thurzov� et al. 1973; Wichtl 2004; European Pharmacopoeia monograph 7.0; Gruenwald et al. 2004]. Urinary tract and genital disorders 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 https://www.ema.europa.eu/en/medicines/herbal/ononidis-radix
Orthosiphonis folium Orthosiphon stamineus Benth. Java Tea The pharmacological effect of a 50% hydro-ethanolic extract of Orthosiphonis herba was studied in pentobarbital-anaesthetized dogs under saline diuresis. The urine volume, excretion of electrolytes (Na+, K+, Cl- ) and fractional water excretion (V/GFR) were significantly increased by IV infusion of the Assessment report on Orthosiphon stamineus Benth., folium EMA/HMPC/135701/2009 Page 14/49 drug (18.8 mg/kg/min) in dogs. Urinary tract and genital disorders urinary tract complaints. The product is a traditional herbal medicinal product for use in specified indication exclusively based on long-standing use https://www.ema.europa.eu/en/medicines/herbal/orthosiphonis-folium
Phaseoli fructus (sine semine) Phaseolus vulgaris L. Green bean pod The herbal substance consists of the dried pericarpium freed of the seeds of Phaseolus vulgaris L. According to the DAC 1986, the water soluble extractive is not less than 12%; the seed fragments are not more than 4%, and foreign matter not more than 2%. Ash is not more than 8% (DAC 1986). Urinary tract and genital disorders 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 https://www.ema.europa.eu/en/medicines/herbal/phaseoli-fructus-sine-semine
Pilosellae herba cum radice Hieracium pilosella L. Mouse-ear hawkweed : Whole or fragmented dry plant of Hieracium pilosella L. Content: minimum 2.5% of ortho-dihydroxycinnamic derivatives, expressed as chlorogenic acid (C16H18O9; Mr 354.3) (dried drug). Urinary tract and genital disorders Traditional herbal medicinal product used to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor https://www.ema.europa.eu/en/medicines/herbal/pilosellae-herba-cum-radice
Pruni africanae cortex Prunus africana (Hook f.) Kalkm. Pygeum africanum bark Pygeum africanum bark consists of the whole or cut, dried bark of the stems and branches of Prunus africana (Hook f.) Kalkm. (synonym: Pygeum africanum Hook f.). The material complies with the existing monograph of the European Pharmacopoeia (European Pharmacopoeia 1886: 2015) Urinary tract and genital disorders The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use https://www.ema.europa.eu/en/medicines/herbal/pruni-africanae-cortex
Sabalis serrulatae fructus Serenoa repens (W. Bartram) Small (Sabal serrulata (Michaux) Nichols) Saw Palmetto Fruit NO DATA Urinary tract and genital disorders NO DATA https://www.ema.europa.eu/en/medicines/herbal/sabalis-serrulatae-fructus
Solidaginis virgaureae herba Solidago virgaurea L. European Goldenrod . Herbal substances contained in such combinations for which an assessment by the HMPC has been performed are Betulae folium, Equiseti herba, Graminis rhizoma (Agropyri repentis rhizoma), Juniperi galbulus (Juniperi pseudo-fructus), Levistici radix, Mate folium, Ononidis radix, Orthosiphonis folium, Phaseoli fructus, Polygoni avicularis herba, Solidaginis virgaureae herba, Urticae folium, Urticae herba and Uvae ursi folium. Urinary tract and genital disorders 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 https://www.ema.europa.eu/en/medicines/herbal/solidaginis-virgaureae-herba
Taraxaci folium Taraxacum officinale Weber ex Wigg. Dandelion Leaf Dandelion leaf consists of the dried leaves of Taraxacum officinale Weber, Compositae, collected before flowering (Bradley PR 1992). Dandelion leaf consists of the dried leaves of Taraxacum officinale Weber collected before flowering (British Herbal Pharmacopoeia 1996). Dandelion leaf consists of the dried leaves of Taraxacum officinale Weber s.l., collected before the flowering period (ESCOP monographs 2003). Urinary tract and genital disorders 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. https://www.ema.europa.eu/en/medicines/herbal/taraxaci-folium
Thymi herba Thymus vulgaris L.; Thymus zygis L. Thyme Whole leaves and flowers separated from the previously dried stems of Thymus vulgaris L. or Thymus zygis L. or a mixture of both species. Minimum content of essential oil: 1.2% with minimum 40% thymol + carvacrol. Urinary tract and genital disorders 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. https://www.ema.europa.eu/en/medicines/herbal/thymi-herba
Urticae folium Urtica dioica L.; Urtica urens L. Nettle Leaf Whole or cut dried leaves of Urtica dioica L., Urtica urens L., or a mixture of the 2 species. Nettle leaf consists of the whole or cut, dried leaves of Urtica dioica L., Urtica urens L., their hybrids or mixtures. (Deutsches Arzneibuch 10, Ausgabe 1991) Urinary tract and genital disorders a) Traditional herbal medicinal product for relief of minor articular pain. 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. https://www.ema.europa.eu/en/medicines/herbal/urticae-folium
Uvae ursi folium Arctostaphylos uva-ursi (L.) Spreng. Bearberry Leaf Bearberry leaf (Uvae ursi folium) consists of whole or cut, dried leaf of Arctostaphylos uva-ursi (L.) Spreng. It contains not less than 7% of anhydrous arbutin (C12H16O7; Mr 272.3), calculated with reference to anhydrous drug determined using HPLC method. The leaf, shiny and dark green on the adaxial surface, lighter on the abaxial surface, is generally 7- 30 mm long and 5-12 mm wide. The entire leaf is obovate with smooth margins, somewhat reflexed downwards, narrowing at the base into a short petiole. The leaf is obtuse or retuse at its apex. The lamina is thick and coriaceous. The venation, pinnate and finely reticulate, is clearly visible on both surfaces. The adaxial surface is marked with sunken veinlets, giving it a characteristic grainy appearance. Only the young leaf has ciliated margins. Old leaves are glabrous. (Ph.Eur. 1054) Urinary tract and genital disorders Traditional herbal medicinal product used for relief 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. https://www.ema.europa.eu/en/medicines/herbal/uvae-ursi-folium
Fragariae folium Fragaria vesca L. Wild Strawberry Leaf Fragaria vescaL. leaves contain phenolic acids, quercetin and quercitrin, 2.2% rutin as well as catechin and ellagitannins, including pedunculagin, together with 5-11% condensed tannins (oligomeric proanthocyanides) (ARS 2016a, Blaschek et al. 2006, Hanhineva et al. 2011, Hiller and Melzig 2003,Sch�nfelder and Sch�nfelder 2004, Van Wyk and Wink 2004, Wagner 1999, Wichtl 1994; 2004). Urinary tract and genital disorders, Gastrointestinal disorders ndication 1)Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints.Indication 2) Traditional herbal medicinal productfor symptomatic https://www.ema.europa.eu/en/medicines/herbal/fragariae-folium
Hippocastani cortex Aesculus hippocastanum L. Horse-chestnut bark Horse chestnut bark. The bark is obtained from the young branches and dried. The composition of horse chesnut bark is complex. The most characteristic compounds are coumarin derivatives (up to 7%) (Wichtl et al. 2003): Urinary tract and genital disorders, Urinary tract and genital disorders 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 https://www.ema.europa.eu/en/medicines/herbal/hippocastani-cortex
Urticae radix Urtica dioica L.; Urtica urens L. Nettle root Nettle root consists of the whole, cut or powdered dried root and rhizomes of Urtica dioica L., Urtica urens L., their hybrids or mixtures of these. British Herbal Pharmacopoeia (BHP) (BHP 1996), British Herbal Compendium (Bradley 2006): Nettle root consist of the dried rhizomes and roots of Urtica dioica L. Phytotherapie in der Urologie (Schilcher & W�lker 1992): Plant sources: Mainly Urtica dioica L., common nettle, but occasionally also U. urens L., small nettle and/or their hybrids. Plant part: the whole subterranean part (rhizome and radix). Urinary tract and genital disorders, Urinary tract and genital disorders 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 https://www.ema.europa.eu/en/medicines/herbal/urticae-radix
Foeniculi amari fructus Foeniculum vulgare Miller subsp. vulgare var. vulgare Bitter Fennel Bitter fennel is characterized by a content of essential oil not lower than 40 ml per kg anhydrous fruit, whereas sweet fennel only contains not less than 20 ml of essential oil per kg anhydrous fruit. The oil in bitter fennel fruits has been reported to contain not less than 60% anethole and 15% fenchone and not more than 6% estragole, whereas in sweet fennel fruits the oil contains not less than 80% anethole (as determined with reference to anethol R that consists of at least 99% transanethole) and not more than 7.5% fenchone and 10% estragole (European Pharmacopoeia, 1/2005:824; European Pharmacopoeia, 1/2005:825; Brand, 1993; T�th, 1967; Trenkle K 1969, 1971 and 1972). The essential oils of bitter and sweet fennels also contain relatively small amounts of alpha-pinene, limonene, p-cymene, beta-pinene, beta-myrcene and of a variety of other compounds (for some examples, see Table 1). Urinary tract and genital disorders, Urinary tract and genital disorders, Cough and cold Traditional use 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. https://www.ema.europa.eu/en/medicines/herbal/foeniculi-amari-fructus
Foeniculi dulcis fructus Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung. Sweet Fennel Bitter fennel is characterized by a content of essential oil not lower than 40 ml per kg anhydrous fruit, whereas sweet fennel only contains not less than 20 ml of essential oil per kg anhydrous fruit. Urinary tract and genital disorders, Urinary tract and genital disorders, Cough and cold usea)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. https://www.ema.europa.eu/en/medicines/herbal/foeniculi-dulcis-fructus
Fraxini folium Fraxinus excelsior L. or Fraxinus angustifolia Vahl Ash Leaf Dried leaf of Fraxinus excelsior L. or F. angustifolia Vahl or hybrids of these 2 species or of a mixture. It contains a minimum of 2.5 per cent of total hydroxycinnamic acid derivatives, expressed as chlorogenic acid (C16H18O9; Mr 354.3) (Ph. Eur. 7.5, 2012). Urinary tract and genital disorders, Urinary tract and genital disorders, Pain and inflammation Traditional use 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. https://www.ema.europa.eu/en/medicines/herbal/fraxini-folium
Adhatodae vasicae folium Adhatoda vasica Nees Malabar-nut leaf NO DATA NO DATA https://www.ema.europa.eu/en/medicines/herbal/adhatodae-vasicae-folium
Allii cepae bulbus Allium cepa L. Onion Allii cepae bulbus consisting of fresh or dried thick and fleshy leaf sheaths and leaf approaches from Allium cepa L. (Monographie BGA/BfArM, 1986; Blaschek et al., 2006). https://www.ema.europa.eu/en/medicines/herbal/allii-cepae-bulbus
Andrographidis paniculatae folium Andrographis paniculata Nees Kalmegh https://www.ema.europa.eu/en/medicines/herbal/andrographidis-paniculatae-folium
Angelicae sinensis radix Angelica sinensis (Oliv.) Diels Winter Cherry Root https://www.ema.europa.eu/en/medicines/herbal/angelicae-sinensis-radix
Balsamum peruvianum Myroxylon balsamum (L.) Harms var. perierae (Royle) Harms Peru balsam Peru balsam is obtained from the scorched and wounded trunk of Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms. It contains not less than 45-70 % m/m of esters, mainly benzyl benzoate and benzyl cinnamate (European Pharmacopeia 01/2008:0754). https://www.ema.europa.eu/en/medicines/herbal/balsamum-peruvianum
Calendulae herba Calendula officinalis L. Marigold NO DATA NO DATA https://www.ema.europa.eu/en/medicines/herbal/calendulae-herba
Caryophylii flos Syzygium aromaticum�(L.) Merill et L.�M. Perry Clove NO DATA NO DATA https://www.ema.europa.eu/en/medicines/herbal/caryophylii-flos
Centellae asiaticae herba Centella asiatica L. Urban Centella According to the European Pharmacopoeia the herbal substance consists of the dried, fragmented aerial parts, containing minimum 6% of total triterpenoid derivatives, expressed as asiaticoside (C48H78O19; Mr 959.15) (IUPAC name: 6-[[3,4-dihydroxy-6-(hydroxymethyl)-5-(3,4,5-trihydroxy-6- methyl-oxan-2-yl)oxy-oxan-2-yl]oxymethyl]-3,4,5-trihydroxy-oxan-2-yl]10,11-dihydroxy-9- (hydroxymethyl)-1,2,6a,6b,9,12a-hexamethyl-2,3,4,5,6,6a,7,8,8a,10,11,12,13,14b-tetradecahydro1H-picene-4a-carboxylate) (European Pharmacopoeia). NO DATA https://www.ema.europa.eu/en/medicines/herbal/centellae-asiaticae-herba
Chelidonii herba Chelidonium majus L. Greater Celandine The European Pharmacopoeia (01/2008:1861) monograph provides the following definition for Chelidonii herba: dried, whole or cut aerial parts of Chelidonium majus L. collected during flowering. Content: minimum 0.6 per cent of total alkaloids, expressed as chelidonine (C20H19NO5; Mr 353.4) (dried drug) NO DATA https://www.ema.europa.eu/en/medicines/herbal/chelidonii-herba
Cisti cretici folium Cistus creticus L. Pink rock-rose NO DATA NO DATA https://www.ema.europa.eu/en/medicines/herbal/cisti-cretici-folium
Citri bergamia aetheroleum Citrus bergamia Risso & Poiteau. Bergamot oil https://www.ema.europa.eu/en/medicines/herbal/citri-bergamia-aetheroleum
Combination: Species sedativae Herbal tea combinations for use as sedatives https://www.ema.europa.eu/en/medicines/herbal/combination-species-sedativae
Euphrasiae herba Euphrasia officinalis L. and Euphrasia rostkoviana Hayne Eyebright https://www.ema.europa.eu/en/medicines/herbal/euphrasiae-herba
Glycini semen Glycine max (L.) Merr. Soya Glycine max (L). Merr., semen (soya bean) is an annual herbaceous plant in the family Fabaceae (legume or bean family) that is cultivated. The fruit contains 1-4 ovoid to spherical seeds of variable colour (Bruneton, 1999). https://www.ema.europa.eu/en/medicines/herbal/glycini-semen
Paeoniae radix alba Paeonia lactiflora Pallas Peony root https://www.ema.europa.eu/en/medicines/herbal/paeoniae-radix-alba
Paeoniae radix rubra Paeonia lactiflora Pall. or Paeonia veitchii Lynch Peony root https://www.ema.europa.eu/en/medicines/herbal/paeoniae-radix-rubra
Picrorhizae kurroae rhizoma et radix Picrorhiza kurroa Royle ex. Benth. Katula https://www.ema.europa.eu/en/medicines/herbal/picrorhizae-kurroae-rhizoma-et-radix
Piperis methystici rhizoma Piper methysticum G. Forst. Kava Kava https://www.ema.europa.eu/en/medicines/herbal/piperis-methystici-rhizoma
Saccharomyces cerevisiae CBS 5926 Saccharomyces cerevisiae CBS 5926 Yeast https://www.ema.europa.eu/en/medicines/herbal/saccharomyces-cerevisiae-cbs-5926
Salviae fruticosae folium Salvia fruticosa Three-lobed sage leaf https://www.ema.europa.eu/en/medicines/herbal/salviae-fruticosae-folium
Salviae officinalis aetheroleum Salvia officinalis L. Sage Oil https://www.ema.europa.eu/en/medicines/herbal/salviae-officinalis-aetheroleum
Sambuci fructus Sambucus nigra L. Elderberry https://www.ema.europa.eu/en/medicines/herbal/sambuci-fructus
Tiliae tomentosae flos Tilia tomentosa Moench Silver lime flower NO DATA NO DATA https://www.ema.europa.eu/en/medicines/herbal/tiliae-tomentosae-flos
Uncariae tomentosae cortex Uncaria tomentosa (Willd. ex Schult.) DC. Cat's Claw One hundred and seventy-eight plant extracts prepared with ethanol 70% (for 48 hours 25?C) from the pharmacopoeia of the Tacana, an ethnic group from Bolivia, were screened for immunmodulatory activity using complement cascade inhibition and ADP-induced platelet aggregation inhibition assays. NO DATA https://www.ema.europa.eu/en/medicines/herbal/uncariae-tomentosae-cortex
Vaccinii macrocarpi fructus Vaccinium macrocarpon Aiton Cranberry NO DATA NO DATA https://www.ema.europa.eu/en/medicines/herbal/vaccinii-macrocarpi-fructus
Visci albi herba Viscum album L. Mistletoe There is no monograph on Mistletoe in the European Pharmacopoeia. As mistletoe can grow and be harvested on several host trees, the origin of the herbal substance can vary. It is not clear what could be the consequences for the human therapeutic use. NO DATA https://www.ema.europa.eu/en/medicines/herbal/visci-albi-herba
Withaniae somniferae radix Withania somnifera (L.) Dunal Winter-cherry root NO DATA NO DATA https://www.ema.europa.eu/en/medicines/herbal/withaniae-somniferae-radix
NO DATA