ASSESSMENT REPORT FOR Rhubarb (Rhei radix) .rhubarb (rhei radix) table of contents . i. regulatory

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Transcript of ASSESSMENT REPORT FOR Rhubarb (Rhei radix) .rhubarb (rhei radix) table of contents . i. regulatory

European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use

7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51

E-mail: mail@emea.europa.eu http://www.emea.europa.eu European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged

London, 5 June 2008

Doc.ref. EMEA/HMPC/189626/2007

ASSESSMENT REPORT FOR Rhubarb (Rhei radix)

TABLE OF CONTENTS I. REGULATORY STATUS OVERVIEW 3

II. ASSESSMENT REPORT FOR HERBAL SUBSTANCE(S), HERBAL PREPARATION(S) OR COMBINATIONS THEREOF WITH WELL-ESTABLISHED USE AND/OR TRADITIONAL USE 4

II.1 INTRODUCTION............................................................................................................................... 5 II.1.1 Description of the herbal substance(s) or herbal preparation(s) thereof ............................. 5 II.1.2 Information on period of medicinal use in the Community regarding the specified indication............................................................................................................................................... 5

II.2 NON-CLINICAL DATA .................................................................................................................... 5 II.2.1 Pharmacology ....................................................................................................................... 5 II.2.1.1 Overview of available data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ................................................................................................................. 6 Assessors overall conclusions on pharmacology ......................................................................... 9 II.2.1.2 ................................................................................................................................................... 9 II.2.2 Pharmacokinetics ................................................................................................................ 10 II.2.2.1 Overview of available data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ............................................................................................................... 10 II.2.2.2 Assessors overall conclusions on pharmacokinetics...................................................... 11 Toxicology.................................................................................................................................... 11 II.2.3 .................................................................................................................................................... 11 II.2.3.1 Overview of available data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof.............................................................................................................................. 11 II.2.3.2 Assessors overall conclusions on toxicology ................................................................. 17

II.3 CLINICAL DATA ........................................................................................................................... 18 II.3.1 Clinical Pharmacology........................................................................................................ 18 II.3.1.1 Pharmacodynamics ......................................................................................................... 18 II.3.1.2 Pharmacokinetics ............................................................................................................ 18 II.3.1.3 Assessors overall conclusions on pharmacodynamics and pharmacokinetics .............. 19 II.3.2 Clinical Efficacy .................................................................................................................. 19 II.3.2.1 Dose response studies...................................................................................................... 19 II.3.2.2 Clinical studies (case studies and clinical trials)............................................................ 19 II.3.2.3 Clinical studies in special populations (e.g. elderly and children) ................................. 22 II.3.2.4 Assessors overall conclusions on clinical efficacy......................................................... 22 II.3.3 Clinical Safety/Pharmacovigilance ..................................................................................... 23 II.3.3.1 Contraindications............................................................................................................ 23 II.3.3.2 Special warning/precautions for use ............................................................................... 23 II.3.3.3 Adverse events ................................................................................................................. 23 II.3.3.4 Overdose.......................................................................................................................... 24 II.3.3.5 Drug abuse ...................................................................................................................... 24 II.3.3.6 Safety in special populations and situations.................................................................... 27 II.3.3.7 Assessors overall conclusions on clinical safety............................................................ 29

II.4 TRADITIONAL USE........................................................................................................................ 29 II.4.1.1 Assessors overall conclusions on traditional use........................................................... 30

II.5 ASSESSORS OVERALL CONCLUSIONS......................................................................................... 30

III. ANNEXES .................................................................................................................................. 31

III.1 PROPOSED COMMUNITY HERBAL MONOGRAPHS FOR .......................................................... 31

III.2 PROPOSAL FOR LIST ENTRY ON .................................................................. 31

III.3 LITERATURE REFERENCES ........................................................................................................... 31

I. EMEA 2008 2/31

REGULATORY STATUS OVERVIEW1

MA: Marketing Authorisation; TRAD: Traditional Use Registration; Other TRAD: Other national Traditional systems of registration; Other: If known, it should be specified or otherwise add Not Known

Member State Regulatory Status Comments2

Austria MA TRAD Other TRAD Other Specify: Belgium MA TRAD Other TRAD Other Specify: Bulgaria MA TRAD Other TRAD Other Specify: Cyprus MA TRAD Other TRAD Other Specify: Czech Republic MA TRAD Other TRAD Other Specify: Denmark MA TRAD Other TRAD Other Specify: Estonia MA TRAD Other TRAD Other Specify: Finland MA TRAD Other TRAD Other Specify: France MA TRAD Other TRAD Other Specify: Germany MA TRAD Other TRAD Other Specify: Greece MA TRAD Other TRAD Other Specify: Hungary MA TRAD Other TRAD Other Specify: Iceland MA TRAD Other TRAD Other Specify: Ireland MA TRAD Other TRAD Other Specify: Italy MA TRAD Other TRAD Other Specify: Latvia MA TRAD Other TRAD Other Specify: Liechtenstein MA TRAD Other TRAD Other Specify: Lithuania MA TRAD Other TRAD Other Specify: Luxemburg MA TRAD Other TRAD Other Specify: Malta MA TRAD Other TRAD Other Specify: The Netherlands MA TRAD Other TRAD Other Specify: Norway MA TRAD Other TRAD Other Specify: Poland MA TRAD Other TRAD Other Specify: Portugal MA TRAD Other TRAD Other Specify: Romania MA TRAD Other TRAD Other Specify: Slovak Republic MA TRAD Other TRAD Other Specify: Slovenia MA TRAD Other TRAD Other Specify: Spain MA TRAD Other TRAD Other Specify: Sweden MA TRAD Other TRAD Other Specify: United Kingdom MA TRAD Other TRAD Other Specify:

1 This regulatory overview is not legally binding and does not necessarily reflect the legal status of the products in

the MSs concerned. 2 Not mandatory field

EMEA 2008 3/31

II. ASSESSMENT REPORT FOR HERBAL SUBSTANCE(S), HERBAL PREPARATION(S) OR COMBINATIONS THEREOF WITH WELL-ESTABLISHED USE AND/OR TRADITIONAL USE

RHUBARB (RHEI RADIX) AND HERBAL PREPARATION(S) THEREOF WITH WELL-ESTABLISHED USE AND/OR TRADITIONAL USE

BASED ON ARTICLE 10A OF DIRECTIVE 2001/83/EC AS AMENDED

(WELL-ESTABLISHED USE)

BASED ON ARTICLE 16 D(1) AND ARTICLE 16F AND 16H OF DIRECTIVE 2001/83/EC AS AMENDED

(TRADITIONAL USE)

Herbal substance(s) (binomial scientific name of the plant, including plant part)

The whole or cut, dried underground parts of Rheum palmatum L. or of Rheum officinale Baillon or of hybrids of these two species or of a mixture

Herbal preparation(s) Standardised herbal preparations thereof

Pharmaceutical forms Herbal substance or preparation for oral use

Rapporteur Dr Werner Knss

EMEA 2008 4/31

II.1 INTRODUCTION

II.1.1 Description of the herbal substance(s) or herbal preparation(s) thereof

Rhubarb belongs to the stimulating laxatives containing hydroxyanthracene derivatives and is intended for short-term use in cases of occasional constipation. Therefore we refer to the assessment reports for senna, aloe, frangulae cortex and cascara.

Constipation is a common complaint in 1-6 % middle-aged and 20-80 % of the elderly people,