Isotretinoin
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the generic isotretinoin-containing medicine from Ranbaxy (UK) Limited. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of this medicine do not outweigh its risks, and the marketing authorisation granted in the United Kingdom cannot be recognised in other Member States of the EU: France and Spain. The marketing authorisation in the United Kingdom should also be suspended.
Key facts
Approved name |
Isotretinoin
|
International non-proprietary name (INN) or common name |
isotretinoin |
Reference number |
EMEA/H/A-29/001276
|
Type |
Article 29(4) referrals
This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health. |
Status |
European Commission final decision
|
Opinion date |
16/12/2010
|
EC decision date |
18/05/2011
|
All documents
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List item
Questions and answers on Isotretinoin Ranbaxy (UK) Limited (isotretinoin 10 and 20 mg capsules) (PDF/51.89 KB)
First published: 17/12/2010
Last updated: 15/07/2011
EMA/820119/2010 -
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List item
Isotretinoin - Article 29 referral - Assessment report (PDF/120.52 KB)
Adopted
First published: 15/07/2011
Last updated: 15/07/2011 -
List item
Isotretinoin - Article 29 referral - Annex I (PDF/47.77 KB)
Adopted
First published: 15/07/2011
Last updated: 15/07/2011 -
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List item
Isotretinoin - Article 29 referral - Annex II (PDF/51.26 KB)
Adopted
First published: 15/07/2011
Last updated: 15/07/2011 -
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List item
Isotretinoin - Article 29 referral - Annex III (PDF/39.96 KB)
Adopted
First published: 15/07/2011
Last updated: 15/07/2011 -
Document description
- Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
- Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents are sometimes available:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies