Prozac

Current status:
European Commission final decision

Overview

The Committee for Medicinal Products for Human Use (CHMP) has completed its arbitration review of Prozac (fluoxetine) and associated names1, and gave a positive opinion to extend its use in the treatment of children suffering from depression, provided that the marketing authorisation holder (MAH), Eli Lilly, carries out additional studies to ensure that the safety profile of Prozac remains acceptable. The new indication is as follows:

Children and adolescents aged 8 years and above: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.

For further information, please refer to the Product Information for Prozac as adopted by the CHMP on 1 June 2006. The document is published for information on the EMEA website, pending formal endorsement by the European Commission

1 Prozac is marketed also under the names of Fluctin, Fluctine, Fluoxétine Lilly, Fluoxétine RPG Prozac, Fontex, Ladose.

Key facts

Approved name
Prozac
International non-proprietary name (INN) or common name
Fluoxetine
Reference number
CHMP/46089/06
Type
Article 6(12) referrals (prior to January 2010)

This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type II). This referral has been replaced by Article 13 referrals.

Status
European Commission final decision
Opinion date
01/06/2006
EC decision date
21/08/2006

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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