- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
On 20 December 1996 Generics (UK) Ltd submitted an application for Mutual Recognition of the Marketing Authorisation granted by the Danish Competent Authorities for Fluoxetin NM, capsules 20 mg. The Mutual Recognition procedure started on 30 January 1997. The Reference Member State was Denmark and the Concerned Member State was Germany. Finland and Sweden had previously granted Marketing Authorisations under national procedures. The Concerned Member State, Germany not being able to agree with the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State referred the reasons for disagreement to the EMEA on 30 April 1997.
The major reasons concerned bioequivalence and possible therapeutic inefficacy related to the switch from the brand leader.
The Reference Member State sent its report to the EMEA on 12 May 1997. The matter was referred to the CPMP on 14 May 1997. Written explanations and further supplementary information were provided by the Marketing Authorisation Holder on 29 August 1997 and 11 December 1997, respectively.
The CPMP adopted a positive Opinion on 17 December 1997 recommending the granting of the Marketing Authorisation for Fluoxetin NM with amendments to the SPC of the Reference Member State.
A copy of the final opinion for Fluoxetin NM is provided on the Internet, together with Annexes A and B and Annex I, which contains the amended SPC.
The final Opinion was converted into a Decision by the European Commission on 9 June 1998.
|International non-proprietary name (INN) or common name||
Article 29(4) referrals
This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.
European Commission final decision
|EC decision date||
Opinion following an Article 10 referral for Fluoxetin NM International Non-Proprietary Name (INN): Fluoxetine: Background information (PDF/22.03 KB)Adopted
First published: 19/06/1998
Last updated: 19/06/1998
Opinion of the Committee for proprietary medicinal products pursuant to Article 10 of Council Directive 75/319/EEC as amended, for Fluoxetin NM (PDF/56.19 KB)Adopted
First published: 10/06/1998
Last updated: 10/06/1998
- 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