Adartrel

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

Overview

Adartrel is a selective dopamine agonist at the D2- and D3-dopamine receptor subtypes and is active both centrally and peripherally.

A Marketing Authorisation for Adartrel was granted to GlaxoSmithKline by France on 30 June 2004. The application for Mutual Recognition for Adartrel were submitted to Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom. The Mutual Recognition Procedure started in September 2004.

The referral procedure was triggered by Spain and The Netherlands, who were of the opinion that this medicinal product might present a risk to public health since the safety and efficacy in long-term treatment of ropinirole in restless legs syndrome had not been demonstrated.

The arbitration procedure started on 15 December 2004. Supplementary information was provided by the Marketing Authorisation Holder on 18 March 2005.

During its 12-15 September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee was of the opinion that a marketing authorisation should be granted subject to certain conditions considered essential for the safe and effective use of the medicinal product. A positive opinion was therefore adopted on 15 September 2005.

The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the Summary of Product Characteristics in the Annex III. Conditions of the Marketing Authorisation are set out in Annex IV.

The final opinion was converted into a Decision by the European Commission on 3 April 2006.

Key facts

Approved name
Adartrel
International non-proprietary name (INN) or common name
Ropinirole
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
15/09/2005
EC decision date
03/04/2006

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:

  • 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

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