Ciclosporin IDL

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

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

Key facts

Approved name
Ciclosporin IDL
International non-proprietary name (INN) or common name
ciclosporin
Reference number
EMEA/H/A-29/1105
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
18/03/2010
EC decision date
22/07/2010

All documents

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:

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