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Assessment Report on Valeriana Officinalis L., Radix and Valeriana Officinalis L., Aetheroleum Final

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Assessment Report on Valeriana Officinalis L., Radix and Valeriana Officinalis L., Aetheroleum Final 02 February 2016 EMA/HMPC/150846/2015 Committee on Herbal Medicinal Products (HMPC) Assessment report on Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum Final 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 Valeriana officinalis L., radix name of the plant, including plant part) Herbal preparation(s) Well-established use Dry extract (DER 3-7.4:1), extraction solvent: ethanol 40-70% (V/V) Traditional use a) Comminuted herbal substance b) Powdered herbal substance c) Expressed juice from fresh root (1:0.60-0.85) d) Dry extract (DER 4-6.1), extraction solvent: water e) Liquid extract (DER 1:4-6), extraction solvent: water f) Dry extract (DER 4-7:1), extraction solvent: methanol 45% (V/V) g) Dry extract (DER 5.3-6.6:1), extraction solvent: methanol 45% (m/m) h) Liquid extract (DER 1:7-9), extraction solvent: sweet vine i) Liquid extract (DER 1:1), extraction solvent: ethanol 60% (V/V) j) Tincture (ratio of herbal substance to extraction solvent 1:8), extraction solvent: ethanol 60% (V/V) k) Tincture (ratio of herbal substance to extraction solvent 1:10), extraction solvent: ethanol 56% l) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 70% (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, 2016. Reproduction is authorised provided the source is acknowledged. Herbal substance(s) (binomial scientific Valeriana officinalis L., radix name of the plant, including plant part) m) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 60-80% (V/V) n) Dry extract (DER 5.5-7.4:1), extraction solvent: ethanol 85% (m/m) Pharmaceutical form(s) Comminuted herbal substance as herbal tea for oral use. Herbal preparation in liquid or solid dosage forms for oral use. Comminuted herbal substance for use as bath additive. Herbal substance(s) (binomial scientific Valeriana officinalis L., aetheroleum name of the plant, including plant part) Herbal preparation(s) Essential oil Pharmaceutical form(s) Herbal preparations in liquid dosage forms for oral use. Herbal preparations in liquid dosage forms for use as bath additive. Rapporteur(s) J. Wiesner Assessor(s) C. Werner; B. Wellnitz Peer-reviewer S. Girotto Assessment report on Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150846/2015 Page 2/67 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 ..................................................................... 7 2. Data on medicinal use ........................................................................................................ 7 2.1. Information about products on the market .............................................................. 7 2.1.1. Information about products on the market in the EU/EEA Member States ................. 7 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 ............ 14 2.3. Overall conclusions on medicinal use .................................................................... 20 3. Non-Clinical Data ............................................................................................................. 22 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 23 3.1.1. Primary pharmacodynamics .............................................................................. 23 3.1.2. Secondary pharmacodynamics .......................................................................... 31 3.1.3. Safety pharmacology ....................................................................................... 32 3.1.4. Pharmacodynamic interactions .......................................................................... 32 3.1.5. Conclusions .................................................................................................... 33 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 34 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ....................................................................... 34 3.3.1. Single dose toxicity .......................................................................................... 34 3.3.2. Repeat dose toxicity ......................................................................................... 35 3.3.3. Genotoxicity ................................................................................................... 35 3.3.4. Carcinogenicity ................................................................................................ 36 3.3.5. Reproductive and developmental toxicity ............................................................ 36 3.3.6. Local tolerance ................................................................................................ 37 3.3.7. Other special studies ........................................................................................ 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 ........................................................................ 38 4.2. Clinical efficacy .................................................................................................. 39 4.2.1. Dose response studies...................................................................................... 39 4.2.2. Clinical studies (case studies and clinical trials) ................................................... 40 4.3. Clinical studies in special populations (e.g. elderly and children) .............................. 54 4.4. Overall conclusions on clinical pharmacology and efficacy ........................................ 55 Assessment report on Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150846/2015 Page 3/67 5. Clinical Safety/Pharmacovigilance ................................................................................... 56 5.1. Overview of toxicological/safety data from clinical trials in humans ........................... 56 5.2. Patient exposure ................................................................................................ 60 5.3. Adverse events, serious adverse events and deaths ................................................ 60 5.4. Laboratory findings ............................................................................................. 61 5.5. Safety in special populations and situations ........................................................... 61 5.5.1. Use in children and adolescents ......................................................................... 61 5.5.2. Contraindications ............................................................................................. 61 5.5.3. Special warnings and precautions for use ........................................................... 61 5.5.4. Drug interactions and other forms of interaction .................................................. 62 5.5.5. Fertility, pregnancy and lactation ....................................................................... 63 5.5.6. Overdose ........................................................................................................ 63 5.5.7. Effects on ability to drive or operate machinery or impairment of mental ability ...... 64 5.5.8. Safety in other special situations ....................................................................... 64 5.6. Overall conclusions on clinical safety ..................................................................... 64 6. Overall conclusions (benefit-risk assessment) ................................................................. 65 Annex .................................................................................................................................
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