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Assessment Report on Cimicifuga Racemosa (L.) Nutt., Rhizoma Final

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Assessment Report on Cimicifuga Racemosa (L.) Nutt., Rhizoma Final 27 March 2018 EMA/HMPC/48744/2017 Committee on Herbal Medicinal Products (HMPC) Assessment report on Cimicifuga racemosa (L.) Nutt., rhizoma Final Based on Article 10a of Directive 2001/83/EC (well-established use) Herbal substance(s) (binomial scientific name of Cimicifuga racemosa (L.) Nutt., rhizoma (black the plant, including plant part) cohosh) Herbal preparations a) Dry extract (DER 5-10:1), extraction solvent ethanol 58% (V/V) b) Dry extract (DER 4.5-8.5:1), extraction solvent ethanol 60% (V/V) c) Dry extract (DER 6-11:1), extraction solvent propan-2-ol 40% (V/V) Pharmaceutical forms Herbal preparation in solid dosage forms for oral use. Rapporteur(s) W. Knöss Assessor(s) S. Flemisch Peer-reviewer C. Cavaleiro Table of contents Table of contents ................................................................................................................... 2 1. Introduction ....................................................................................................................... 6 Description of the herbal substance(s), herbal preparation(s) or combinations thereof ......... 6 1.1. 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 .................................. 18 2.2. Information on documented medicinal use and historical data from literature ............ 18 2.3. Overall conclusions on medicinal use .................................................................... 19 3. Non-Clinical Data ............................................................................................................. 20 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 20 3.1.1. Primary pharmacodynamics .............................................................................. 21 3.1.2. Secondary pharmacodynamics .......................................................................... 23 3.1.3. Safety pharmacology ....................................................................................... 24 3.1.4. Pharmacodynamic interactions .......................................................................... 25 3.1.5. Conclusions .................................................................................................... 25 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 25 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ....................................................................... 26 3.3.1. Single dose toxicity .......................................................................................... 26 3.3.2. Repeat dose toxicity ......................................................................................... 26 3.3.3. Genotoxicity ................................................................................................... 26 3.3.4. Carcinogenicity ................................................................................................ 26 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 ................................................................ 27 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 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 29 4.2. Clinical efficacy .................................................................................................. 30 4.2.1. Dose response studies...................................................................................... 30 4.2.2. Clinical studies (case studies and clinical trials) ................................................... 30 4.3. Clinical studies in special populations (e.g. elderly and children) .............................. 49 4.4. Overall conclusions on clinical pharmacology and efficacy ........................................ 51 5. Clinical Safety/Pharmacovigilance ................................................................................... 54 5.1. Overview of toxicological/safety data from clinical trials in humans ........................... 54 Assessment report on Cimicifuga racemosa (L.) Nutt., rhizoma EMA/HMPC/48744/2017 Page 2/68 5.2. Patient exposure ................................................................................................ 58 5.3. Adverse events, serious adverse events and deaths ................................................ 58 5.4. Laboratory findings ............................................................................................. 62 5.5. Safety in special populations and situations ........................................................... 62 5.5.1. Use in children, adolescents and men ................................................................. 64 5.5.2. Contraindications ............................................................................................. 64 5.5.3. Special warnings and precautions for use ........................................................... 64 5.5.4. Drug interactions and other forms of interaction .................................................. 65 5.5.5. Fertility, pregnancy and lactation ....................................................................... 65 5.5.6. Overdose ........................................................................................................ 66 5.5.7. Effects on ability to drive or operate machinery or impairment of mental ability ...... 66 5.5.8. Safety in other special situations ....................................................................... 66 5.6. Overall conclusions on clinical safety ..................................................................... 66 6. Overall conclusions (benefit-risk assessment) ................................................................. 66 Annex .................................................................................................................................. 68 List of abbreviations Assessment report on Cimicifuga racemosa (L.) Nutt., rhizoma EMA/HMPC/48744/2017 Page 3/68 The acronyms and abbreviations commonly used in the context of EU herbal monograph establishment by the HMPC please refer to the document “Abbreviations used in HMPC agendas/minutes” (EMA/HMPC/441838/2013) available here: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/11/WC500155666.pdf http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/document_listing/document_ listing_000193.jsp&mid=WC0b01ac0580028e96 AACE American Association of Clinical Endocrinologists ALT alanine aminotransferase ANCOVA analysis of covariance AP alkaline phosphatase AST aspartate aminotransferase BDI Beck’s depression inventory CE conjugated oestrogens CEE conjugated equine oestrogens CGI clinical global impression scale CHD coronary heart disease CI confidence interval CR CR CT computer tomography CYP cytochrome p450 DILI drug induced liver injury E2 oestradiol ER oestrogen receptor ESCOP European Scientific Cooperative On Phytotherapy FSH follicle stimulating hormone γ-GT / GGT gamma glutamyl transferase GCP Good Clinical Practice GOT glutamic oxaloacetic transaminase=AST GPT glutamic pyruvic transaminase= ALT GCS Greene Climacteric Scale HAMA Hamilton anxiety scale HAMD Hamilton depression scale HD high dose HDL high density lipoproteins Assessment report on Cimicifuga racemosa (L.) Nutt., rhizoma EMA/HMPC/48744/2017 Page 4/68 HED human equivalent dose HILI herb induced liver injury HT hormone therapy I(i)CR isopropanolic CR dry extract IGF-1 Insulin-like growth factor IM intramuscular IP intraperitoneal ITT intention-to-treat KI Kupperman Index LD low dose LDH lactate dehydrogenase LDL low density lipoproteins LH luteinising hormone MPA medroxyprogesterone acetate MMTV mouse mammary tumour virus MRCP magnetic resonance cholangiopancreatography MRS I menopause rating scale I MRS II menopause rating scale II NOAEL no-observed-adverse-effect level pg/mL picogram
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