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Assessment Report on Mentha X Piperita L. Folium and Aetheroleum

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Assessment Report on Mentha X Piperita L. Folium and Aetheroleum 15 January 2020 EMA/HMPC/522409/2013 Committee on Herbal Medicinal Products (HMPC) Assessment report on Mentha x piperita L., folium and aetheroleum Final – Revision 1 Based on Article 10a of Directive 2001/83/EC (well-established use) Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC (traditional use) Herbal substance(s) (binomial scientific name of Mentha x piperita L. the plant, including plant part) Whole or cut dried leaf of Mentha x piperita L. Herbal preparation(s) Mentha x piperita, folium (TU) a) Comminuted herbal substance b) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 45% (V/V) c) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 70% (V/V) Mentha x piperita, aetheroleum (TU and WEU) Essential oil (obtained by steam distillation from the fresh aerial parts of the flowering plant). Pharmaceutical form(s) Mentha x piperita, folium (TU) Herbal substance or comminuted herbal substance as herbal tea for oral use. Herbal preparations in solid or liquid dosage forms for oral use. Mentha x piperita, aetheroleum (TU) Herbal preparations in liquid or solid dosage forms for oral and oromucosal use. 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 Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Herbal preparations in liquid dosage forms for inhalation. Herbal preparations in liquid or semi-solid dosage forms for cutaneous or transdermal use. Mentha x piperita, aetheroleum (WEU) Herbal preparations in solid gastro–resistant dosage forms for oral use. Herbal preparations in liquid or semi-solid dosage forms for cutaneous use. Rapporteur(s) Helena Pinto Ferreira Peer-reviewer Zoi Karampourmpouni Expert Ioanna Chinou Assessment report on Mentha x piperita L., folium and aetheroleum EMA/HMPC/522409/2013 Page 2/101 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 ................................. 15 2.2. Information on documented medicinal use and historical data from literature............ 15 2.3. Overall conclusions on medicinal use ................................................................... 19 3. Non-Clinical Data ............................................................................................................. 26 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................... 26 3.1.1. Primary pharmacodynamics ............................................................................ 26 3.1.2. Secondary pharmacodynamics ........................................................................ 30 3.1.3. Safety pharmacology ..................................................................................... 34 3.1.4. Pharmacodynamic interactions ........................................................................ 34 3.1.5. Conclusions .................................................................................................. 35 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................... 35 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ..................................................................... 37 3.3.1. Single dose toxicity ........................................................................................ 37 3.3.2. Repeat dose toxicity ...................................................................................... 37 3.3.3. Genotoxicity ................................................................................................. 38 3.3.4. Carcinogenicity ............................................................................................. 39 3.3.5. Reproductive and developmental toxicity .......................................................... 39 3.3.6. Local tolerance .............................................................................................. 40 3.3.7. Other special studies ...................................................................................... 40 3.3.8. Conclusions .................................................................................................. 40 3.4. Overall conclusions on non-clinical data ............................................................... 41 4. Clinical Data ..................................................................................................................... 43 4.1. Clinical pharmacology ....................................................................................... 43 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 43 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 47 4.2. Clinical efficacy ................................................................................................ 48 4.2.1. Dose response studies.................................................................................... 48 4.2.2. Clinical studies (case studies and clinical trials) .................................................. 48 4.3. Clinical studies in special populations (e.g. elderly and children) ............................. 80 4.4. Overall conclusions on clinical pharmacology and efficacy ...................................... 80 5. Clinical Safety/Pharmacovigilance ................................................................................... 84 5.1. Overview of toxicological/safety data from clinical trials in humans .......................... 84 Assessment report on Mentha x piperita L., folium and aetheroleum EMA/HMPC/522409/2013 Page 3/101 5.2. Patient exposure .............................................................................................. 88 5.3. Adverse events, serious adverse events and deaths .............................................. 89 5.4. Laboratory findings .......................................................................................... 91 5.5. Safety in special populations and situations ......................................................... 91 5.5.1. Use in children and adolescents ....................................................................... 91 5.5.2. Contraindications........................................................................................... 91 5.5.3. Special warnings and precautions for use .......................................................... 92 5.5.4. Drug interactions and other forms of interaction ................................................ 93 5.5.5. Fertility, pregnancy and lactation ..................................................................... 93 5.5.6. Overdose ..................................................................................................... 94 5.5.7. Effects on ability to drive or operate machinery or impairment of mental ability ...... 94 5.5.8. Safety in other special situations ..................................................................... 94 5.6. Overall conclusions on clinical safety ................................................................... 95 6. Overall conclusions (benefit-risk assessment) ................................................................. 95 Annex ................................................................................................................................ 101 Assessment report on Mentha x piperita L., folium and aetheroleum EMA/HMPC/522409/2013 Page 4/101 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof Herbal substance(s) The herbal substance consists of whole or cut dried leaf of Mentha x piperita L. Peppermint is a perennial plant native to Europe, highly aromatic, which may grow as tall as 90 cm. According to the European Pharmacopoeia, it contains a minimum of 12 ml/kg of essential oil for the whole drug and a minimum of 9 ml/kg of essential oil for the cut drug (Ph. Eur. Ref.: 0406). Mentha x piperita L. is believed to be a hybrid of spearmint (Mentha spicata L) and water
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