Seroquel XR

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

Overview

Outcome of a procedure under Article 6(13) of Regulation (EC) 1084/2003 as amended.

The European Medicines Agency has completed an arbitration procedure for Seroquel XR and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that Seroquel XR can be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.

Key facts

Approved name
Seroquel XR
International non-proprietary name (INN) or common name
quetiapine
Reference number
EMEA/H/6(13)/001188
Type
Article 6(13) referrals (prior to January 2010)

This type of referral was triggered by the marketing-authorisation holder for a medicine that had been authorised by mutual recognition or via the decentralised procedure when Member States could not accept the variation (type II).

Status
European Commission final decision
Opinion date
22/04/2010
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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