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Assessment Report on Echinacea Purpurea (L.) Moench., Herba Recens

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Assessment Report on Echinacea Purpurea (L.) Moench., Herba Recens 24 November 2014 EMA/HMPC/557979/2013 Committee on Herbal Medicinal Products (HMPC) Assessment report on Echinacea purpurea (L.) Moench., herba recens 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) Final – revision for systematic review Herbal substance(s) (binomial scientific name of Echinacea purpurea (L.) Moench., herba recens the plant, including plant part) Herbal preparation(s) Expressed juice from fresh herb (DER 1.5-2.5:1); Dried juice corresponding to the expressed juice above Pharmaceutical forms Herbal preparations in liquid or solid dosage forms for oral use and in liquid or semi-solid dosage forms for cutaneous use Rapporteurs S. Kreft and B. Razinger Peer-reviewer J. Wiesner 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged. Table of contents Table of contents ................................................................................................................... 2 1. Introduction ....................................................................................................................... 4 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof .. 4 1.2. Search and assessment methodology ..................................................................... 6 2. Data on medicinal use ........................................................................................................ 7 2.1. Information about products on the market in the EU/EEA Member States .................... 7 2.2. Information on traditional/current indications and specified substances/preparations .. 20 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications ....................................................................................... 23 3. Non-Clinical Data ............................................................................................................. 24 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 24 3.1.1. Antiviral Effects ............................................................................................... 24 3.1.2. Antibacterial Effects ......................................................................................... 26 3.1.3. Effects on wound healing .................................................................................. 26 3.1.4. Immunomodulatory effects ............................................................................... 27 3.1.5. Anti-inflammatory effects ................................................................................. 30 3.1.6. Antioxidative effects ........................................................................................ 31 3.1.7. Antifungal effects ............................................................................................ 31 3.1.8. Safety Pharmacology ....................................................................................... 32 3.1.9. Pharmacodynamic Interactions .......................................................................... 32 3.1.10. Conclusions ................................................................................................... 32 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 32 3.2.1. Pharmacokinetic interactions ............................................................................. 33 3.2.2. Conclusions .................................................................................................... 35 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ....................................................................... 35 3.3.1. Single-Dose Toxicity ........................................................................................ 35 3.3.2. Repeat-Dose Toxicity ....................................................................................... 36 3.3.3. Genotoxicity ................................................................................................... 36 3.3.4. Carcinogenicity ................................................................................................ 36 3.3.5. Reproductive and developmental Toxicity ........................................................... 36 3.3.6. Local tolerance ................................................................................................ 37 3.3.7. Immunotoxicity ............................................................................................... 37 3.3.8. Conclusions .................................................................................................... 37 3.4. Overall conclusions on non-clinical data ................................................................ 37 4. Clinical Data ..................................................................................................................... 38 4.1. Clinical Pharmacology ......................................................................................... 38 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/ preparation(s) including data on relevant constituents ........................................................................ 38 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 40 4.2. Clinical Efficacy .................................................................................................. 43 Assessment report on Echinacea purpurea (L.) Moench., herba recens EMA/HMPC/557979/2013 Page 2/73 4.2.1. Dose response studies...................................................................................... 43 4.2.2. Clinical studies (case studies and clinical trials) ................................................... 43 4.3. Clinical studies in special populations (e.g. elderly and children) .............................. 54 4.4. Overall conclusions on clinical pharmacology and efficacy ........................................ 57 5. Clinical Safety/Pharmacovigilance ................................................................................... 59 5.1. Overview of toxicological/safety data from clinical trials in humans ........................... 59 5.2. Patient exposure ................................................................................................ 60 5.3. Adverse events, serious adverse events and deaths ................................................ 60 5.4. Laboratory findings ............................................................................................. 66 5.5. Safety in special populations and situations ........................................................... 66 5.5.1. Use in children and adolescents ......................................................................... 66 5.5.2. Contraindications ............................................................................................. 67 5.5.3. Special Warnings and precautions for use ........................................................... 67 5.5.4. Drug interactions and other forms of interaction .................................................. 67 5.5.5. Fertility, pregnancy and lactation ....................................................................... 68 5.5.6. Overdose ........................................................................................................ 70 5.5.7. Effects on ability to drive or operate machinery or impairment of mental ability ...... 70 5.5.8. Safety in other special situations ....................................................................... 70 5.6. Overall conclusions on clinical safety ..................................................................... 70 6. Overall conclusions (benefit-risk assessment) ................................................................. 71 Annex .................................................................................................................................. 73 Assessment report on Echinacea purpurea (L.) Moench., herba recens EMA/HMPC/557979/2013 Page 3/73 1. Introduction This Assessment report (and corresponding monograph) is a priori limited to Echinacea purpurea (L.) Moench., herba recens and preparations thereof. Therefore the medicinal products containing the roots of the same plant (or the combination of roots and herb) and other plant species are out of the scope of this document. Nevertheless some data on the research on products with roots and other Echinacea species are given for information. 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof • Herbal substance(s) Echinacea purpurea (L.) Moench., herba recens The monograph in the European Pharmacopoeia (reference 01/2008:1823) defines only the dry herbal substance “Purple coneflower herb” as:
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