Valproate

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.

The review was carried out under an 'Article 31' referral1.

The European Commission issued a decision on 26 August 2010.

1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.

Key facts

Approved name
Valproate
International non-proprietary name (INN) or common name
Valproic acid/valproate
Reference number
EMEA/H/A-31/1163, EMEA/H/A-6(12)/1147
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
17/12/2009
EC decision date
26/08/2010

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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