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Rhodiola Rosea L., Rhizoma Et Radix

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12 July 2011 EMA/HMPC/232100/2011 Committee on Herbal Medicinal Products (HMPC) Assessment report on Rhodiola rosea L., rhizoma et radix Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use) Draft Herbal substance(s) (binomial scientific name of Rhodiola rosea L., rhizoma et radix the plant, including plant part) Herbal preparation(s) Dry extract (DER 1.5-5:1), extraction solvent ethanol 67-70% v/v Pharmaceutical forms Herbal preparations in solid dosage forms for oral use. Note: This Assessment Report is published to support the release for public consultation of the draft Community herbal monograph on Rhodiola rosea L., rhizoma et radix. It should be noted that this document is a working document, not yet fully edited, and which shall be further developed after the release for consultation of the monograph. Interested parties are welcome to submit comments to the HMPC secretariat, which the Rapporteur and the MLWP will take 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 monograph. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. Table of contents Table of contents ...................................................................................................................2 1. Introduction.......................................................................................................................3 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof .3 1.2. Information about products on the market in the Member States .............................. 5 Regulatory status overview ........................................................................................ 5 1.3. Search and assessment methodology.................................................................... 6 2. Historical data on medicinal use ........................................................................................6 2.1. Information on period of medicinal use in the Community ........................................ 6 2.2. Information on traditional/current indications and specified substances/preparations ... 6 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications....................................................................................... 7 3. Non-Clinical Data ...............................................................................................................7 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 7 Pharmacological data regarding the herbal preparation: ................................................. 7 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................... 22 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ..................................................................... 23 3.4. Overall conclusions on non-clinical data............................................................... 23 4. Clinical Data.....................................................................................................................24 4.1. Clinical Pharmacology ....................................................................................... 24 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 24 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 25 4.2. Clinical Efficacy ................................................................................................ 25 4.2.1. Dose response studies.................................................................................... 25 4.2.2. Clinical studies (case studies and clinical trials).................................................. 25 4.2.3. Clinical studies in special populations (e.g. elderly and children)........................... 30 4.3. Overall conclusions on clinical pharmacology and efficacy ...................................... 30 5. Clinical Safety/Pharmacovigilance...................................................................................31 5.1. Overview of toxicological/safety data from clinical trials in humans.......................... 31 5.2. Patient exposure .............................................................................................. 31 5.3. Adverse events and serious adverse events and deaths ......................................... 31 5.4. Laboratory findings .......................................................................................... 31 5.5. Safety in special populations and situations ......................................................... 31 5.6. Overall conclusions on clinical safety................................................................... 32 6. Overall conclusions ..........................................................................................................32 Annex ..................................................................................................................................32 List of references.................................................................................................... 32 Assessment report on Rhodiola rosea L., rhizoma et radix EMA/HMPC/232100/2011 Page 2/32 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof Herbal substance(s) The herbal substance consists of the dried roots and rhizomes of Rhodiola rosea L., Crassulaceae. Although the plant part in use is commonly referred to as the root, the anatomy of these parts reveals that these parts are underground stems (rhizomes) with irregular secondary thickening. The plant is native throughout the mountains in the Northern Hemisphere. A main source of commercially available rhizomes is the Altai region in Asia (Panossion et al. 2010). Common names are: Roseroot, Rosenroot, Golden Root, Arctic Root, Rosenwurz. The name refers to the rose-like fragrance of the fresh cut underground organs. Constituents (according to Panossion et al. 2010, Ali et al. 2008, Tolonen et al. 2003): Phenylalkanoids: Phenylethanoids (e.g salidroside [Syn. rhodioloside]: p-hydroxyphenylethyl-O-ß- D-glucopyranoside), phenylpropenoids (e.g. rosin: cinnamyl-O-ß-D- glucopyranoside; rosarin: (cinnamyl-(6’-O-α-L-arabinofuranosyl)- O-ß-D- glucopyranoside; rosavin: (cinnamyl-(6’-O-α-L- arabinopyranosyl)- O-ß-D- glucopyranoside), phenylpropanes (e.g. tyrosol). Only limited data are available regarding the quantitative composition. Hellum et al. 2010 report a considerable variability between clones of Rhodiola rosea in Norway based on data obtained from ethanolic extracts (primary extraction solvent ethanol 96%). Irrespective of the plant origin (cultivated in Lithuania or naturally occurring in Altai Mountains) Kucinskaite et al. (2007) found in aqueous- ethanolic extracts 1.35-1.62 mg/ml of salidroside, while the profile of rosavines differed considerably. Ethanol 70% v/v yields extracts with a low content of salidroside compared to ethanol 40% v/v; in contrast rosavins are more efficiently extracted by ethanol 70% (Kucinskaite 2007). Essential oil: The dried rhizome contains approximately 0.05% of essential oil. Main components are α-pinene, geraniol, limonene, ß-phellandrene, linalool, n-octanol, n-decanol, dodecanol, 1,4-p- menthadien-7-ol and cumin alcohol (Rohloff 2002). Evstatieva et al. (2010) found considerable differences in the composition of the essential oil of different origin. In a sample from Bulgaria, myrtenol and meraniol counted for more than 75%; in an Indian sample phenethylalcohol was the main component (56%); in a sample from China, geraniol (57%) and n-octanol were the dominating components. Monoterpene derivatives: rosiridol, rosiridin, rhodiolosides A-E. Cyanogenic glycosides: rhodiocyanoside A, lotaustralin Proanthocyanidines: prodelphinidine-gallate esters Flavonolignans: rhodiolin Flavonoids: Rhodiola-specific flavonoids like rhodionidin, rhodiolgin, rhodalidin, rhodionin, rhodiolgidin, rhodalin, rhodiosin; tricin and kaempferol derivatives. Phenolic acids: chlorogenic acid, hydroxycinnamic acid Herbal preparation(s) Dry extract (DER 1.5-5:1), extraction solvent ethanol 67-70% v/v Assessment report on Rhodiola rosea L., rhizoma et radix EMA/HMPC/232100/2011 Page 3/32 Combinations of herbal substance(s) and/or herbal preparation(s) including a description of vitamin(s) and/or mineral(s) as ingredients of
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