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Assessment Report on Allium Sativum L., Bulbus Final

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Assessment Report on Allium Sativum L., Bulbus Final 18 July 2017 EMA/HMPC/7686/2013 Committee on Herbal Medicinal Products (HMPC) Assessment report on Allium sativum L., bulbus Final Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use) Herbal substance(s) (binomial scientific Allium sativum L., bulbus name of the plant, including plant part) Herbal preparation(s) Powdered herbal substance Liquid extract from fresh bulb (DER 2-3:1), extraction solvent rapeseed oil, refined Dry extract (DER 5:1), extraction solvent ethanol 34%, V/V Pharmaceutical forms Herbal preparation in solid dosage forms for oral use Rapporteur J. Viguet Poupelloz; Corrections: P. Duez Assessor(s) Clinical: L. Boudali, D. Boucaud-Maitre Non-clinical: E. Grangier Peer reviewer I. Chinou Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us An agency of the European Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 Union © European Medicines Agency, 2020. 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 ............................................................. 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 ................................. 12 2.2. Information on documented medicinal use and historical data from literature............ 12 2.3. Overall conclusions on medicinal use ................................................................... 15 3. Non-Clinical Data ............................................................................................................. 16 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................... 16 3.1.1. Primary pharmacodynamics ............................................................................ 17 3.1.2. Secondary pharmacodynamics ........................................................................ 19 3.1.3. Safety pharmacology ..................................................................................... 19 3.1.4. Pharmacodynamic interactions ........................................................................ 20 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................... 20 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ..................................................................... 21 3.3.1. Single dose toxicity ........................................................................................ 21 3.3.2. Repeat dose toxicity ...................................................................................... 26 3.3.3. Genotoxicity ................................................................................................. 34 3.3.4. Carcinogenicity ............................................................................................. 37 3.3.5. Reproductive and developmental toxicity .......................................................... 37 3.3.6. Local tolerance .............................................................................................. 37 3.3.7. Other special studies ...................................................................................... 37 3.4. Overall conclusions on non-clinical data ............................................................... 37 4. Clinical Data ..................................................................................................................... 39 4.1. Clinical pharmacology ....................................................................................... 39 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 39 4.1.1.1. Pharmacodynamics of relevant herbal preparations ......................................... 39 4.1.1.2. Pharmacodynamic data ............................................................................... 40 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 40 4.2. Clinical efficacy ................................................................................................ 42 4.2.1. Dose response studies.................................................................................... 42 4.2.2. Clinical studies (case studies and clinical trials) .................................................. 42 4.2.2.1. Antilipidemic effects .................................................................................... 42 4.2.2.2. Antihypertensive effects .............................................................................. 53 4.2.2.3. Antithrombotic effects/Cardiovascular morbidity and mortality .......................... 59 4.2.2.4. Treatment of upper respiratory infections ....................................................... 64 Assessment report on Allium sativum L., bulbus EMA/HMPC/7686/2013 Page 2/90 4.2.2.5. Prevention and treatment of symptoms of common cold ................................... 64 4.2.2.6. Hypoglycaemic effects ................................................................................. 66 4.2.2.7. Treatment of tick bites ................................................................................ 70 4.2.2.8. Cancer prevention ...................................................................................... 71 4.3. Clinical studies in special populations (e.g. elderly and children) ............................. 78 4.4. Overall conclusions on clinical pharmacology and efficacy ...................................... 79 5. Clinical Safety/Pharmacovigilance ................................................................................... 83 5.1. Overview of toxicological/safety data from clinical trials in humans .......................... 83 5.2. Patient exposure .............................................................................................. 83 5.3. Adverse events, serious adverse events and deaths .............................................. 83 5.4. Laboratory findings .......................................................................................... 84 5.5. Safety in special populations and situations ......................................................... 84 5.5.1. Use in children and adolescents ....................................................................... 84 5.5.2. Contraindications........................................................................................... 85 5.5.3. Special Warnings and precautions for use ......................................................... 85 5.5.4. Drug interactions and other forms of interaction ................................................ 85 5.5.5. Fertility, pregnancy and lactation ..................................................................... 87 5.5.6. Overdose ..................................................................................................... 87 5.5.7. Effects on ability to drive or operate machinery or impairment of mental ability ...... 87 5.5.8. Safety in other special situations ..................................................................... 87 5.6. Overall conclusions on clinical safety ................................................................... 88 6. Overall conclusions (benefit-risk assessment) ................................................................. 88 Annex .................................................................................................................................. 90 Assessment report on Allium sativum L., bulbus EMA/HMPC/7686/2013 Page 3/90 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof The aim of this report is to assess the non-clinical and clinical data available on Allium sativum for preparing a European Union herbal monograph. This report is based on the documentation published in the literature. Herbal substance(s) Allium sativum L., bulbus The composition of Allium bulbus is complex. Garlic contains volatile oil (0.1-0.36%), the major components are sulfur compounds like alliin. It contains also proteins (amino acids, glutamyl peptides), glucides, enzymes (alliinase, peroxidase, myrosinase). Allicin is formed from alliin by the alliinase. It is considered that 1 mg of alliin is equivalent to 0.45 mg of allicin
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