- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
On 23 April 2009, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Ciclosporin IDL. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Ciclosporin IDL do not outweigh its risks, and that the marketing authorisation granted in the Netherlands cannot be recognised in other Member States of the EU and that the marketing authorisation in the Netherlands should be suspended.
The company that markets Ciclosporin IDL, International Drug Licensing, requested a re-examination of the opinion. After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the recommendation for the refusal and suspension of the marketing authorisation on 23 July 2009.
The review was carried out under an 'Article 29' referral1.
A European Commission decision on this opinion will be issued in due course.
1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
|International non-proprietary name (INN) or common name||
European Commission final decision
|EC decision date||
Questions and answers on the referral for Ciclosporin IDL and associated names capsules containing ciclosporin 25 mg, 50 mg and 100 mg - Re-examination (PDF/118.34 KB)Adopted
First published: 23/07/2009
Last updated: 20/11/2013
Questions and answers on the referral for Ciclosporin IDL and associated names capsules containing ciclosporin 25 mg, 50 mg and 100 mg - Initial (PDF/33.27 KB)Adopted
First published: 23/04/2009
Last updated: 23/04/2009
Ciclosporin IDL - Article-30 referral - Annex I, II, III (PDF/44.33 KB)
First published: 20/11/2013
Last updated: 20/11/2013
- 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