Valproate
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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
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About this medicine
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|---|---|
| Approved name |
Valproate
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| International non-proprietary name (INN) or common name |
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About this procedure
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|---|---|
| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-31/1163, EMEA/H/A-6(12)/1147
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| 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. |
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
17/12/2009
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| EC decision date |
26/08/2010
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All documents
Valproate - Article 31 - Annex I (PDF/460.09 KB)
First published: 29/04/2011
Last updated: 29/04/2011
Valproate - Article 31 - Annex II (PDF/70.51 KB)
First published: 29/04/2011
Last updated: 29/04/2011
Valproate - Article 31 - Annex III (PDF/64.86 KB)
First published: 29/04/2011
Last updated: 29/04/2011
Valproate - Article 31 - Annex IV (PDF/54.26 KB)
First published: 29/04/2011
Last updated: 29/04/2011
European Commission final decision
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.