Valproat Ratiopharm Chrono

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

Overview

The European Medicines Agency has completed a review of the safety and effectiveness of valproate in the treatment of manic episodes in bipolar disorder. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of valproate in this condition outweigh their risks, and that all marketing authorisations for medicines containing valproate throughout Europe should be amended to include the treatment of manic episodes in bipolar disorders when lithium is contraindicated or not tolerated.

Key facts

Approved name
Valproat Ratiopharm Chrono
International non-proprietary name (INN) or common name
valproic acid / valproate
Reference number
EMEA/H/A-6(12)/1147
Type
Article 6(12) referrals (prior to January 2010)

This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type II). This referral has been replaced by Article 13 referrals.

Status
European Commission final decision
Opinion date
25/05/2010
EC decision date
26/05/2010

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:

  • 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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