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Draft Assessment Report on Saccharomyces Cerevisiae CBS 5926

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Draft Assessment Report on Saccharomyces Cerevisiae CBS 5926 05 May 2021 EMA/HMPC/625623/2015 Committee on Herbal Medicinal Products (HMPC) Assessment report on Saccharomyces cerevisiae CBS 5926 Draft 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 name of Saccharomyces cerevisiae CBS 5926 the plant, including plant part) Herbal preparation(s) Not applicable Pharmaceutical form(s) Not applicable Rapporteur(s) J Wiesner Assessor(s) F Stolte B Merz F Deget Peer-reviewer A Assissi Note: This draft assessment report is published to support the release for public consultation of the draft public statement on Saccharomyces cerevisiae CBS 5926. It is a working document, not yet edited, and shall be further developed after the release for consultation of the public statement. Interested parties are welcome to submit comments to the HMPC secretariat, which will be taken into consideration but no ‘overview of comments received during the public consultation’ will be prepared in relation to the comments that will be received on this assessment report. The publication of this draft assessment report has been agreed to facilitate the understanding by Interested Parties of the assessment that has been carried out so far and led to the preparation of the draft public statement. 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, 2021. 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 ................................ 20 2.2. Information on documented medicinal use and historical data from literature ........... 21 2.3. Overall conclusions on medicinal use .................................................................. 22 3. Non-Clinical Data ............................................................................................................ 23 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 ........................................................................ 26 3.1.3. Safety pharmacology .................................................................................... 26 3.1.4. Pharmacodynamic interactions ....................................................................... 26 3.1.5. Conclusions ................................................................................................. 27 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 ..................................................................... 28 3.3.1. Single dose toxicity ........................................................................................ 28 3.3.2. Repeat dose toxicity ...................................................................................... 28 3.3.3. Genotoxicity ................................................................................................ 29 3.3.4. Carcinogenicity ............................................................................................. 29 3.3.5. Reproductive and developmental toxicity .......................................................... 29 3.3.6. Local tolerance ............................................................................................. 29 3.3.7. Other special studies ..................................................................................... 29 3.3.8. Conclusions ................................................................................................. 30 3.4. Overall conclusions on non-clinical data .............................................................. 30 4. Clinical Data .................................................................................................................... 31 4.1. Clinical pharmacology ...................................................................................... 31 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 31 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 34 4.2. Clinical efficacy ............................................................................................... 35 4.2.1. Dose response studies ................................................................................... 35 4.2.2. Clinical studies (case studies and clinical trials) ................................................. 35 4.3. Clinical studies in special populations (e.g. elderly and children) ............................ 88 4.4. Overall conclusions on clinical pharmacology and efficacy ..................................... 158 Assessment report on Saccharomyces cerevisiae CBS 5926 EMA/HMPC/625623/2015 Page 2/174 5. Clinical Safety/Pharmacovigilance ................................................................................ 167 5.1. Overview of toxicological/safety data from clinical trials in humans ........................ 167 5.2. Patient exposure ............................................................................................. 167 5.3. Adverse events, serious adverse events and deaths ............................................. 167 5.4. Laboratory findings .......................................................................................... 168 5.5. Safety in special populations and situations ........................................................ 168 5.5.1. Use in children and adolescents ..................................................................... 169 5.5.2. Contraindications ......................................................................................... 169 5.5.3. Special Warnings and precautions for use ....................................................... 170 5.5.4. Drug interactions and other forms of interaction ............................................... 170 5.5.5. Fertility, pregnancy and lactation ................................................................... 171 5.5.6. Overdose.................................................................................................... 171 5.5.7. Effects on ability to drive or operate machinery or impairment of mental ability .... 171 5.5.8. Safety in other special situations .................................................................... 171 5.6. Overall conclusions on clinical safety ................................................................. 171 6. Overall conclusions (benefit-risk assessment) .............................................................. 172 Annex ................................................................................................................................ 174 List of references ................................................................................................... 174 Assessment report on Saccharomyces cerevisiae CBS 5926 EMA/HMPC/625623/2015 Page 3/174 1. Introduction Disclaimer Due to the initial decision of the HMPC to conduct a scientific assessment in order to possibly establish a monograph on Saccharomyces cerevisiae, a draft assessment report and draft EU monograph supporting a traditional and well-established use on herbal medicinal products containing Saccharomyces cerevisiae CBS 5926 were prepared in line with EMA/HMPC standard procedures and principles based on Article 10a of Directive 2001/83/EC (well-established use) and based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC (traditional use). However, no absolute majority required for adoption of the monograph was achieved and the HMPC is of the opinion that a European Union herbal monograph on Saccharomyces cerevisiae CBS 5926 cannot be established due to different opinions on the classification of this yeast. On one hand, yeasts
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