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Assessment Report on Fragaria Vesca L., Fragaria Moschata Weston, Fragaria Viridis Weston and Fragaria X Ananassa (Weston) Duchesne Ex Rozier, Folium Final

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Assessment Report on Fragaria Vesca L., Fragaria Moschata Weston, Fragaria Viridis Weston and Fragaria X Ananassa (Weston) Duchesne Ex Rozier, Folium Final 20 November 2018 EMA/HMPC/432276/2015 Committee on Herbal Medicinal Products (HMPC) Assessment report on Fragaria vesca L., Fragaria moschata Weston, Fragaria viridis Weston and Fragaria x ananassa (Weston) Duchesne ex Rozier, folium Final Based on Article 16d (1), Article 16f and Article 16h of Directive 2001/83/EC (traditional use) Herbal substance(s) (binomial scientific name of the plant, Fragaria vesca L., Fragaria moschata West., Fragaria viridis West. including plant part) and Fragaria x ananassa (West.) Duchesne ex Rozier folium Herbal preparation(s) Comminuted herbal substance Pharmaceutical forms Comminuted herbal substance as herbal tea for oral use Rapporteur Ewa Widy-Tyszkiewicz Peer-reviewer Olga Palomino . 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, 2019. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Introduction ....................................................................................................................... 4 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof ................ 4 1.2. Search and assessment methodology .................................................................................. 10 2. Data on medicinal use ...................................................................................................... 10 2.1. Information about products on the market .......................................................................... 10 2.1.1. Information about products on the market in the EU/EEA Member States ............................. 10 2.1.2. Information on products on the market outside the EU/EEA ................................................ 10 2.2. Information on documented medicinal use and historical data from literature .......................... 10 2.3 Overall conclusions on medicinal use .................................................................................. 12 3. Non-Clinical Data ............................................................................................................. 13 3.1 Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................................... 13 3.1.1. Primary pharmacodynamics ............................................................................................ 13 3.1.2. Secondary Pharmacodynamics ........................................................................................ 14 3.1.3. Pharmacodynamic interactions ........................................................................................ 26 3.1.4. Conclusions................................................................................................................... 26 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................................... 27 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof .......................................................................................................... 27 3.3.1. Single dose toxicity ........................................................................................................ 27 3.3.2. Repeated dose toxicity ................................................................................................... 27 3.3.3. Genotoxicity .................................................................................................................. 27 3.3.4. Carcinogenicity .............................................................................................................. 27 3.3.5. Reproductive and developmental toxicity .......................................................................... 27 3.3.6. Local tolerance .............................................................................................................. 27 3.3.7. Other special studies ...................................................................................................... 27 3.3.8. Conclusions................................................................................................................... 27 3.4. Overall conclusions on non-clinical data ............................................................................... 28 4. Clinical Data ..................................................................................................................... 28 4.1. Clinical pharmacology ....................................................................................................... 28 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ................................................................................................... 28 4.2. Clinical Efficacy ................................................................................................................ 28 4.2.1. Dose response studies .................................................................................................... 28 4.2.2. Clinical studies (case studies and clinical trials) ................................................................. 28 4.3. Clinical studies in special populations (e.g. elderly and children) ............................................. 28 4.4. Overall conclusions on clinical pharmacology and efficacy ...................................................... 28 5. Clinical Safety/Pharmacovigilance ................................................................................... 29 5.1. Overview of toxicological/safety data from clinical trials in humans ......................................... 29 5.2. Patient exposure .............................................................................................................. 29 5.3. Laboratory findings ........................................................................................................... 29 5.4. Safety in special populations and situations ......................................................................... 29 5.4.1. Use in children and adolescents ....................................................................................... 29 Assessment report on Fragaria vesca L., Fragaria moschata Weston, Fragaria viridis Weston and Fragaria x ananassa (Weston) Duchesne ex Rozier, folium EMA/HMPC/432276/2015 Page 2/31 5.4.2. Contraindications ........................................................................................................... 29 5.4.3. Special Warnings and precautions for use ......................................................................... 29 5.4.4. Drug interactions and other forms of interaction ................................................................ 30 5.4.5. Fertility, pregnancy and lactation ..................................................................................... 30 5.4.6. Overdose ...................................................................................................................... 30 5.4.7. Effects on ability to drive or operate machinery or impairment of mental ability .................... 30 5.4.8. Safety in other special situations ..................................................................................... 30 5.5. Overall conclusions on clinical safety ................................................................................... 30 6. Overall conclusions .......................................................................................................... 30 Annex .................................................................................................................................. 31 List of references ................................................................................................................. 31 Assessment report on Fragaria vesca L., Fragaria moschata Weston, Fragaria viridis Weston and Fragaria x ananassa (Weston) Duchesne ex Rozier, folium EMA/HMPC/432276/2015 Page 3/31 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof • Herbal substance(s) Wild strawberry belongs to the genus Fragaria and it grows spontaneously throughout Europe, North America and North Asia. Wild strawberry images were commonly shown in medieval paintings (Sillasoo, 2006). The existing species of Fragaria are estimated to have last shared a common ancestor between 1.0 and 4.1 million years ago (Liston et al. 2014). The genus Fragaria consists of at least 20 recognised wild species with different chromosome numbers (ie. 2x, 4x, 6x and 8x) (Hummer et al. 2011). After analysis of chloroplast DNA it was found that Fragaria vesca is the closest diploid (2x) relative to the cultivated octoploid strawberry Fragaria ananassa (8x) (Sargent et al. 2009). Diploid Fragaria vesca L. was cultivated since the Middle Ages in European gardens, together with two other wild species with different chromosome numbers found in European forests: hexaploid F. moschata L., diploid F. viridis Duchenne and a form of the so-called "semperflorens or alpine” (Darrow 1966). The cultivated strawberry originated
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