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Hyperici Herba (Pharm 30 January 2018 EMA/HMPC/244315/2016 Committee on Herbal Medicinal Products (HMPC) Assessment report on Hypericum perforatum L., herba Draft 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) Herbal substance(s) (binomial scientific Hypericum perforatum L., herba name of the plant, including plant part) Herbal preparation(s) Traditional use a) Dry extract (DER 4-7:1), extraction solvent ethanol 38% (m/m) = 45% V/V b) Liquid extract (DER 1:4-20), extraction solvent vegetable oil c) Liquid extract (DER 1:13), extraction solvent maize oil or other suitable vegetable oil d) Tincture (ratio herbal substance : extraction solvent 1:10), extraction solvent ethanol 45-50% (V/V) e) Liquid extract (DER 1:2-7), extraction solvent ethanol 50% (V/V) f) Expressed juice from the fresh herb (DER 1:0.5-0.9) g) Comminuted herbal substance h) Powdered herbal substance Well-established use a) Dry extract (DER 3-7:1), extraction solvent methanol (80% V/V) b) Dry extract (DER 3-6:1), extraction solvent ethanol (80% V/V) 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, 2018. Reproduction is authorised provided the source is acknowledged. c) Dry extract (DER 2.5-8:1), extraction solvent ethanol (50-68% V/V) Pharmaceutical form(s) Comminuted herbal substance as herbal tea for oral use. Herbal preparations a, h in solid dosage forms for oral use. Herbal preparations b, c, d, e, f in liquid dosage forms for oral use. Herbal preparations b, d, e in liquid or semi-solid dosage forms for cutaneous use. Well-established use Herbal preparation in solid dosage forms for oral use. Rapporteur(s) R. Länger Assessor(s) R. Länger Peer-reviewer G. Calapai/ C. Cavaleiro Note: This draft assessment report is published to support the release for public consultation of the draft European Union herbal monograph on Hypericum perforatum L. herba. It should be noted that this document is a working document, not yet edited, and which shall be further developed after the release for consultation of the monograph public statement. 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. Assessment report on Hypericum perforatum L., herba EMA/HMPC/244315/2016 Page 2/144 Table of contents Table of contents ................................................................................................................... 3 1. Introduction ....................................................................................................................... 5 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof .. 5 1.2. Search and assessment methodology ..................................................................... 8 2. Data on medicinal use ........................................................................................................ 8 2.1. Information about products on the market .............................................................. 8 2.1.1. Information about products on the market in the EU/EEA Member States ................. 8 2.1.2. Information on products on the market outside the EU/EEA .................................. 14 2.2. Information on documented medicinal use and historical data from literature ............ 15 2.3. Overall conclusions on medicinal use .................................................................... 16 Non-Clinical Data ................................................................................................................. 18 2.4. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 18 2.4.1. Primary pharmacodynamics .............................................................................. 18 2.4.1.1. Primary pharmacodynamics related to the treatment of depression ..................... 18 2.4.1.2. Primary pharmacodynamics related to wound healing ........................................ 30 2.4.2. Secondary pharmacodynamics .......................................................................... 32 2.4.3. Safety pharmacology ....................................................................................... 54 2.4.4. Pharmacodynamic interactions .......................................................................... 54 2.5. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 54 2.6. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ....................................................................... 59 2.6.1. Single dose toxicity .......................................................................................... 59 2.6.2. Repeat dose toxicity ......................................................................................... 59 2.6.3. Genotoxicity ................................................................................................... 60 2.6.4. Carcinogenicity ................................................................................................ 60 2.6.5. Reproductive and developmental toxicity ............................................................ 60 2.6.6. Local tolerance ................................................................................................ 63 2.6.7. Other special studies ........................................................................................ 63 2.6.8. Conclusions .................................................................................................... 65 2.7. Overall conclusions on non-clinical data ................................................................ 65 3. Clinical Data ..................................................................................................................... 65 3.1. Clinical pharmacology ......................................................................................... 65 3.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 65 3.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 68 3.2. Clinical efficacy .................................................................................................. 70 3.2.1. Dose response studies...................................................................................... 70 3.2.2. Clinical studies (case studies and clinical trials) ................................................... 70 3.3. Clinical studies in special populations (e.g. elderly and children) ............................ 107 3.4. Overall conclusions on clinical pharmacology and efficacy ...................................... 108 Assessment report on Hypericum perforatum L., herba EMA/HMPC/244315/2016 Page 3/144 4. Clinical Safety/Pharmacovigilance ................................................................................. 109 4.1. Overview of toxicological/safety data from clinical trials in humans ......................... 109 4.2. Patient exposure .............................................................................................. 121 4.3. Adverse events, serious adverse events and deaths .............................................. 121 4.4. Laboratory findings ........................................................................................... 123 4.5. Safety in special populations and situations ......................................................... 123 4.5.1. Use in children and adolescents ....................................................................... 123 4.5.2. Contraindications ........................................................................................... 123 4.5.3. Special Warnings and precautions for use ......................................................... 123 4.5.4. Drug interactions and other forms of interaction ................................................ 123 4.5.5. Fertility, pregnancy and lactation ..................................................................... 140 4.5.6. Overdose ...................................................................................................... 141 4.5.7. Effects on ability to drive or operate machinery or impairment of mental ability .... 141 4.5.8. Safety in other special situations ..................................................................... 142 4.6. Overall conclusions on clinical safety ..................................................................
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