- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
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.
|International non-proprietary name (INN) or common name||
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 This referral has been replaced by Article 13 referrals.
European Commission final decision
|EC decision date||
Questions and answers on the review of Prozac for use in children and adolescents (PDF/39.82 KB)Adopted
First published: 06/06/2006
Last updated: 06/06/2006
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information (PDF/39.76 KB)Adopted
First published: 21/08/2006
Last updated: 21/08/2006
Prozac- Article 6 (12) referral - Annex I, II, III (PDF/304.7 KB)Adopted
First published: 05/09/2006
Last updated: 05/09/2006
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.