30 Churchill Place - PDF document

30 Churchill Place 䌀愀渀愀爀礀⁗栀愀爀昀  䰀漀渀搀漀渀⁅㄀㐀  㕅唀 唀渀椀琀攀搀 䬀椀渀最搀漀洀 䄀渀⁡最攀渀挀礀昀⁴ 栀攀⁅甀爀漀瀀攀愀渀⁕渀椀漀渀† Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact 2017 . Reproduction is authorised provi ded the source is acknowledged. May 2017EMA/HMPC/424583/2016Committee on Herbal Medicinal Products (HMPC)European Unionherbal monograph on Echinacea purpurea(L.) Moench, radixFinalInitial assessment Jul y 2009 Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation July End of consultation (deadline for comments) 15 Dec ember 2009 discussion in MLWPJanuary Mar ch 2010 Adoption by HMonograph (EMA/HMPC/577784/200AR (EMA/HMPC//200List of references (EMA/HMPC//200Overview HMPC Opinion (EM A/HMPC/ 153975 /20 10 ) March First systematic revi ew Discussion in orking arty on European Union monographs and list (MLWP) July 2016 Adoption by Committee on Herbal Medicinal Products (HMPCfor release for consultation 22 November 2016 End of consultation (deadline for comments 1 )

15 March 2017 Re - discussion in MLWP March 2017 Adoption by HMPC 30 May 2017 No comments were received during the period of public consultation. Therefore the final monograph is published together with the final assessment report and list of references, without an ‘Overview of comments received during the public consultation’ European Union herbal monograph on Echinacea purpurea (L.) Moench, radix EMA/HMPC/424583/2016 Page 2 / 7 eywords Herbal medicinal products; HMPC; European Unionherbal monographs; traditional use;Echinacea purpurea(L.) Moench, radix; Echinaceae purpureae radix; purple coneflow er root BG (blgarski): Пурпурна ехинацея, коренCS (čeština): kořen třapatky nachovéDA (dansk): Purpur solhatrodDE (Deutsch): PurpursonnenhutwurzelEL (elliniká): εχινκεαπορφυρζαEN (English): purple coneflower root ES (espaol): Equinácea purpúrea, raíz deET (eesti keel): punase siilkübara juurFI (suomi): kaunopunahattu, juuriFR (français): echinacée pourpre (racine d')HR (hrvatski): korijen purpurne rudbekijeHU (magyar): bíbor kasvirág virágos gyökér IT (italiano): Echinacea purpurea radice LT

(lietuvių kalba): Rausvažiedžių ežiuolių šaknysLV (latviešu valoda): Sarkanās ehinacejas saknesalti): gherq ta' lechinacea vjolaNL (ederlands): Paarse ZonnehoedPL (polski): Korzeń jeżówki purpurowejPT (português): Equinácea purpúrea, raizRO (română)rădăcină de echinacea/pălăria soareluiSK (slovenčina): oreň echinacey purpurovejSL (slovenščina): korenina škrlatne ehinacejeSV (svenska): öd solhatt, rotIS (íslenska) NO (norsk): r ød solhatt, rot European Union herbal monograph on Echinacea purpurea (L.) Moench, radix EMA/HMPC/424583/2016 Page 3 / 7 European Unionherbal monograph on Echinacea purpurea(L.) Moench, radix1. Name of the medicinal productTo be specified for the individual finished product.2. Qualitative and quantitative compositionWellestablished use Traditional use With regard to the registration application of Article 16d(1) of Directive2001/83/EC Echinacea purpurea(L.) Moench, radix (purple coneflower root)i) Herbal substanceNot applicableii) Herbal preparationsry extract (DER 5.57.5:1), extraction solvent ethanol 45% (V/V ry extract (DER 4:1);extraction solvent water 3. harmaceutical formWellestablished useTraditional use Herbal preparations in so

lid dosage forms for oral and oromucosal use.The pharmaceutical form should be described by the European Pharmacopoeia full standard term. 4. Clinical particulars 4.1. Therapeutic indicationsWellestablished use Traditional use Indication 1) Traditional herbal medicinal product or the relief of symptoms of common cold The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.The material complies with the Ph. Eur. monograph (ref.: 1824 European Union herbal monograph on Echinacea purpurea (L.) Moench, radix EMA/HMPC/424583/2016 Page 4 / 7 Wellestablished use Traditional use Indication 2) Traditional herbal medicinal product used for the reliefof spots and pimples due to mild acne.he product is a traditional herbal medicinal product for use in the specified indicationexclusively based upon longstanding use. 4.2. Posology and method of administrationWellestablished use Traditional use Posology Indication 1) Dry extract (DER 57.5:1)Adolescentsdultsand elderlySingle dose: 40 mg of extractevery second hourDaily dose: 360 mg (40 mgtimesdaily Indication 2) Dry extract (DER 4:1)Adult

s and elderlySingle dose: 50100 mg of extractDaily dose: 150300 mg of extracAdolescentsSingle dose: 50 mg of extractDaily dose: 100 mg of extractThe use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).Duration of use Indication 1) The therapy should start atthefirst signs of common cold. If the symptoms persist longer than 10 daysduring the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. European Union herbal monograph on Echinacea purpurea (L.) Moench, radix EMA/HMPC/424583/2016 Page 5 / 7 Wellestablished use Traditional use Indication 2) If the symptoms persist longer than 2 weeksduring the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.Method of administration Indication 1) Oral and oromucosal use Indication 2) Oral use 4.3. ContraindicationsWellestablished use Traditional use Hypersensitivity to the active substance andotherplants of the Asteraceae (Compositae) family. 4.4. Special warnings and precautions for useWellestablished use Traditional use The use is not recommended in cases of progressive systemic disorder

s, autoimmune diseases, immunodeficiencies, immunosuppression and diseases of the white blood cell system. If the symptoms worsen or high fever occurs during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.There is a possible risk of allergic reactions in sensitive individuals. Those patients should consult their doctor before using EchinaceaThere is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor before using EchinaceaThe use in children under 12 years of age has not been established due to lack of adequate data. European Union herbal monograph on Echinacea purpurea (L.) Moench, radix EMA/HMPC/424583/2016 Page 6 / 7 4.5. Interactions with other medicinal products and other forms of interactionWellestablished use Traditional use None reported 4.6. Fertility, pregnancy and lactationWellestablished use Traditional use Safety during pregnancy and lactation has not been established.In the absence of sufficient data, the use during pregnancy and lactation is not recommended.No fertility data available. 4.7. ffects on ability to drive and use machinesWellestablished use Traditional use No studies

on the effect on the ability to drive and use machines have been performed. 4.8. Undesirable effectsWellestablished use Traditional use Hypersensitivity reactions (skin reactions) may occur. The frequency is not known.If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted. 4.9. OverdoseWellestablished use Traditional use No case of overdose has been reported. 5. harmacological properties5.1. Pharmacodynamic propertiesWellestablished use Traditional use Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC. European Union herbal monograph on Echinacea purpurea (L.) Moench, radix EMA/HMPC/424583/2016 Page 7 / 7 5.2. Pharmacokinetic propertiesWellestablished use Traditional use Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC. 5.3. Preclinical safety dataWellestablished useTraditional use Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/E, unless necessary for the safe use of the product.Tests on reproductive toxicitygenotoxicity and carcinogenicity have not been performed. 6. harmaceutical particularsWellestablished useTraditional use Not applicable 7. ate of compilation/last revisionMay 2