Efexor

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

Overview

Efexor, 25 mg, 37.5 mg, 50 mg, 75 mg, tablets, is an antidepressant indicated for the treatment of major depressive episodes and for the prevention of recurrence of major depressive episodes.

On 3 May 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Efexor.

The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Efexor approved across EU Member States, with respect to the treatment of major depressive episodes and for the prevention of recurrence of major depressive episodes.

This medicinal product belongs to the 2007 list of products identified for SPC harmonisation.

The procedure started on 24 May 2007. The Marketing Authorisation Holder provided supplementary information on 26 September 2007.

During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.

The CHMP gave a positive opinion on 24 July 2008 with a subsequent revision on 25 September 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Efexor.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.

A Decision was issued by the European Commission on 28 November 2008.

Key facts

Approved name
Efexor
International non-proprietary name (INN) or common name
venlafaxine
Reference number
CHMP/384875/2008
Type
Article 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Status
European Commission final decision
Opinion date
24/07/2008
EC decision date
28/11/2008

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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