Simvastatin Vale

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

Overview

On 25 March 2013, 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 Simvastatin Vale. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Simvastatin Vale outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway.

Key facts

Approved name
Simvastatin Vale
International non-proprietary name (INN) or common name
simvastatin
Associated names
Simvastatin Vale pharmaceuticals
Class
Statin
Reference number
EMEA/H/A-29/1358
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
25/03/2013
EC decision date
27/05/2013

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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