- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Outcome of a procedure under Article 30 of Directive 2001/83/EC
The European Medicines Agency has completed a review of a group of generic escitalopram-containing medicines that were authorised via a decentralised procedure. The Agency's Committee for Medicinal Products for Human Use (CHMP) has noted that there is a need to harmonise the decisions taken in European Union (EU) Member States involved in this decentralised procedure on whether to maintain or suspend the marketing authorisations of these medicines. The CHMP concluded that marketing authorisations for the medicines should be suspended.
A European Commission decision on this opinion will be issued in due course.
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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.
Opinion provided by Committee for Medicinal Products for Human Use
Questions and answers on generic escitalopram-containing medicines (tablets containing escitalopram oxalate, 5, 10, 15 and 20 mg) (PDF/55.4 KB)Adopted
First published: 20/02/2010
Last updated: 20/02/2010
- 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