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Assessment Report on Althaea Officinalis L., Radix Final

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Assessment Report on Althaea Officinalis L., Radix Final 12 July 2016 EMA/HMPC/436680/2015 Committee on Herbal Medicinal Products (HMPC) Assessment report on Althaea officinalis L., radix 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 name of Althaea officinalis L., radix the plant, including plant part) Herbal preparation(s) Comminuted herbal substance Liquid extract (DER 1:19.5–23.5), extraction solvent water Macerate for preparation of syrup Dry extract (DER 3–9:1), extraction solvent water Liquid extract (DER 1:1), extraction solvent ethanol 25% (V/V) Pharmaceutical form(s) Comminuted herbal substance as herbal tea for oral use. Comminuted herbal substance for macerate preparation for oromucosal use. Herbal preparations in liquid or solid dosage forms for oral or oromucosal use. Rapporteur(s) M. Heroutová Peer-reviewer G. Laekeman 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. 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 ..................................................................... 7 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 .................................. 13 2.2. Information on documented medicinal use and historical data from literature ............ 13 2.3. Overall conclusions on medicinal use .................................................................... 20 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. Primary pharmacodynamics .............................................................................. 24 3.1.2. Secondary pharmacodynamics .......................................................................... 29 3.1.3. Safety pharmacology ....................................................................................... 30 3.1.4. Pharmacodynamic interactions .......................................................................... 30 3.1.5. Conclusions .................................................................................................... 30 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 31 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ....................................................................... 31 3.3.1. Single dose toxicity .......................................................................................... 31 3.3.2. Repeat dose toxicity ......................................................................................... 31 3.3.3. Genotoxicity ................................................................................................... 31 3.3.4. Carcinogenicity ................................................................................................ 31 3.3.5. Reproductive and developmental toxicity ............................................................ 31 3.3.6. Local tolerance ................................................................................................ 31 3.3.7. Other special studies ........................................................................................ 31 3.3.8. Conclusions .................................................................................................... 31 3.4. Overall conclusions on non-clinical data ................................................................ 32 4. Clinical Data ..................................................................................................................... 32 4.1. Clinical pharmacology ......................................................................................... 32 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 32 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 32 4.2. Clinical efficacy .................................................................................................. 32 4.2.1. Dose response studies...................................................................................... 32 4.2.2. Clinical studies (case studies and clinical trials) ................................................... 32 4.3. Clinical studies in special populations (e.g. elderly and children) .............................. 36 4.4. Overall conclusions on clinical pharmacology and efficacy ........................................ 36 5. Clinical Safety/Pharmacovigilance ................................................................................... 37 5.1. Overview of toxicological/safety data from clinical trials in humans ........................... 37 Assessment report on Althaea officinalis L., radix EMA/HMPC/436680/2015 Page 2/42 5.2. Patient exposure ................................................................................................ 39 5.3. Adverse events, serious adverse events and deaths ................................................ 39 5.4. Laboratory findings ............................................................................................. 39 5.5. Safety in special populations and situations ........................................................... 39 5.5.1. Use in children and adolescents ......................................................................... 39 5.5.2. Contraindications ............................................................................................. 39 5.5.3. Special warnings and precautions for use ........................................................... 39 5.5.4. Drug interactions and other forms of interaction .................................................. 40 5.5.5. Fertility, pregnancy and lactation ....................................................................... 40 5.5.6. Overdose ........................................................................................................ 40 5.5.7. Effects on ability to drive or operate machinery or impairment of mental ability ...... 40 5.5.8. Safety in other special situations ....................................................................... 40 5.6. Overall conclusions on clinical safety ..................................................................... 41 6. Overall conclusions (benefit-risk assessment) ................................................................. 41 Annex .................................................................................................................................. 42 Assessment report on Althaea officinalis L., radix EMA/HMPC/436680/2015 Page 3/42 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof Herbal substance(s) In accordance with the European Pharmacopoeia (8th ed., 01/2012:1126) marshmallow root (Althaeae radix) consists of peeled or unpeeled, whole or cut, dried root of Althaea officinalis L. It has a swelling index of minimum 10, determined on the powdered herbal substance. The unpeeled, non-fragmented drug consists of cylindrical, slightly twisted roots, up to 2 cm thick, with deep longitudinal furrows. The outer surface is greyish-brown and bears numerous rootlet scars. The fracture is fibrous externally, rugged and granular internally. The section shows a more or less thick, whitish bark with brownish periderm, separated by the well-marked, brownish cambium from a white xylem. The stratified structure of the bark and the radiate structure of xylem become more distinct when moistened. The peeled drug has a greyish-white, finely fibrous outer surface. Cork and external cortical parenchyma are absent (European Pharmacopoeia 8th ed., 01/2012:1126). The roots are collected in the autumn from plants not less than two years old (British Pharmaceutical Codex 1949; Hänsel et al., 1993; Bradley, 1992). Herbal preparation(s) Comminuted herbal substance (for macerate preparation) Liquid extract (DER 1:19.5-23.5), extraction solvent water Dry extract (DER 3-9:1), extraction solvent water Macerate for preparation
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