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Assessment Report on Achillea Millefolium L., Herba

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Assessment Report on Achillea Millefolium L., Herba 15 September 2010 EMA/HMPC/290309/2009 Committee on Herbal Medicinal Products (HMPC) Assessment report on Achillea millefolium L., herba <Based on Article 10a of Directive 2001/83/EC as amended (well-established use)> <Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use)> Draft Herbal substance(s) (binomial scientific name of the plant, including plant part) Achillea millefolium L., herba Herbal preparation(s) - Comminuted herbal substance - expressed juice (DER 1:0.6-0.9) from fresh herb - liquid extract (DER 1:1) extraction solvent ethanol 25% (V/V) - tincture (1:5), extraction solvent: ethanol 31.5% (V/V) - tincture (1:5), extraction solvent: ethanol 45% (V/V) Pharmaceutical forms Comminuted herbal substance as herbal tea for oral use or cutaneous use. Herbal preparations in liquid dosage forms for oral use. Note: This draft Assessment Report is published to support the release for public consultation of the draft Community herbal monograph on Achillea millefolium L., herba. It should be noted that this document is a working document, not yet fully edited, and which shall be further developed after the release for consultation of the monograph. Interested parties are welcome to submit comments to the HMPC secretariat, which the Rapporteur and the MLWP will take into consideration but no ‘overview of comments received during the public consultation’ will be prepared in relation to the comments that will be received on this assessment report. The publication of this draft assessment report has been agreed to facilitate the understanding by Interested Parties of the assessment that has been carried out so far and led to the preparation of the draft monograph. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged. Table of contents Table of contents ...................................................................................................................2 1. Introduction.......................................................................................................................3 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof .3 1.1.1. Phytochemical characteristics............................................................................ 4 1.2. Information about products on the market in the Member States .............................. 5 1.3. Search and assessment methodology.................................................................... 7 2. Historical data on medicinal use .......................................................... ..... .........................7 2.1. Information on period of medicinal use in the Community ........................................ 7 2.2. Information on traditional/current indications and specified substances/preparations ... 8 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications..................................................................................... 10 3. Non-Clinical Data .............................................................................................................11 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................... 11 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................... 16 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ..................................................................... 16 3.4. Overall conclusions on non-clinical data............................................................... 18 4. Clinical Data.....................................................................................................................19 4.1. Clinical Pharmacology ....................................................................................... 19 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 19 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 19 4.2. Clinical Efficacy ................................................................................................ 19 4.2.1. Dose response studies.................................................................................... 19 4.2.2. Clinical studies (case studies and clinical trials).................................................. 19 4.2.3. Clinical studies in special populations (e.g. elderly and children)........................... 20 4.3. Overall conclusions on clinical pharmacology and efficacy ...................................... 20 5. Clinical Safety/Pharmacovigilance...................................................................................20 5.1. Overview of toxicological/safety data from clinical trials in humans.......................... 20 5.2. Patient exposure .............................................................................................. 20 5.3. Adverse events and serious adverse events and deaths ......................................... 20 5.4. Laboratory findings .......................................................................................... 21 5.5. Safety in special populations and situations ......................................................... 22 5.6. Overall conclusions on clinical safety................................................................... 23 6. Overall conclusions ..........................................................................................................23 Annex ..................................................................................................................................23 Assessment report on Achillea millefolium L., herba EMA/HMPC/290309/2009 2/23 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof Herbal substance(s) Definition: - The whole or cut dried flowering tops of yarrow, Achillea millefolium This definition can be found in: European Pharmacopoeia 6th ed. (2008) Yarrow Extra Pharmacopoeia Martindale XXV. Edition (Todd RG 1976) Herbal Medicines (Newal CA et al. 1996), (Barnes J at al. 2007) WHO Monographs (Volume 4, 2009) ESCOP Monographs (Supplement 2009) - Fresh or dried aerial (aboveground) part collected during the flowering season of Achillea millefolium This definition can be found in: Pharmacopoea Hungarica Editio VI. Tomus III, 1967 Hagers Handbuch der Pharmazeutischen Praxis 1969 (Kern W.) German Comission E Monograph 1990 British Herbal Pharmacopoeia 1996 (dried aerial parts) British Herbal Compendium Volume 1, 1992 (dried aerial parts) WHO Monographs (Volume 4, 2009) ESCOP Monographs (Supplement 2009) Assessor’s comment: MLWP decided to use the definition of European Pharmacopoeia 6th ed. (2008) Yarrow on it March meeting 2010. Herbal preparation(s) Communited herbal substance as infusion for tea preparation (Augustin B 1948, Todd RG 1967, BHP 1974, Rácz G et al. 1984, German Commission E monograph 1990, Blumenthal M et al. 1990, Wren RC 1988, Bisset NG 1994, Newal CA et al. 1996, Hänsel R et al. 1992, Bradley R 1992) Expressed juice (1:1) from fresh herb (Blumenthal M et al. 1990, Hänsel R et al. 1992) Liquid extract (1:1), extraction solvent: ethanol 25% (V/V) (Wren RC 1988, Bradley R 1992, Newal CA et al. 1996, BHP 1974) Tincture (1:5), extraction solvent: ethanol 45% (V/V) (Bradley R 1992, Newal CA et al. 1996, BHP 1974) Assessment report on Achillea millefolium L., herba EMA/HMPC/290309/2009 3/23 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. Millefolii herba is a frequent component of combinations mainly for mild cramp-like, gastrointestinal complaints, catarrh and lost of appetite. 1.1.1. Phytochemical characteristics Achillea millefolium L. s.l. is a cytogenetically, morphologically, and chemically polymorphic aggregate. The genus Achillea consists of about 140 perennial herbs native to the Northern hemisphere. Principal components of the herbal substance Yarrow contains 3-4% condensed and hydrolysable tannins; 0.3-1.4% volatile oils, mostly linalool, borneol, camphor, β-caryophyllene, 1.8-cineole, and sesquiterpene lactones composed of guaianolides, mainly achillicin (a proazulene), achillin, leucodin, and germacranolides (dihydroparthenolide, achillifolin, millefin); flavonoids (apigenin, luteolin, isorhamnetin, rutin); amino acids (alanine, histidine, leucine, lysine); fatty acids (linoleic, palmitic, oleic); phenolic acids (caffeic, salicylic); vitamins (ascorbic acid, folic acid); alkaloids and bases (achiceine, achilleine, betaine, choline); alkanes (tricosane); polyacetylenes; saponins; sterols (β-sitosterol); sugars (dextrose, glucose,
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