Prozac

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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.

Why did the CHMP review this medicine?

Prozac is currently authorised for use in adults to treat depression, obsessive-compulsive disorders and bulimia nervosa (an eating disorder) within the European Union.

Following a request from the UK, the MAH for Prozac submitted an application for the extension of the indications to treat depression in children and adolescents, via the mutual recognition procedure2. The review was initiated by France on the basis of safety and efficacy concerns on the use of Prozac in this age group.

2 This is a procedure whereby Member States mutually recognise marketing authorisations within the European Union. In case of disagreement during the procedure, the issue is referred to the CHMP for arbitration.

What data has the CHMP reviewed?

The CHMP reviewed data submitted by the MAH, which included data from experimental models, clinical studies and information published in scientific journals.

Efficacy was supported by three main studies, involving over 750 children and adolescents. All studies compared the efficacy of Prozac in the treatment of depression with that of a placebo (dummy treatment) over 9 to 12 weeks. The CHMP also reviewed safety data from experimental and clinical studies on growth, sexual development and suicide-related behaviour (suicide attempt and suicidal thoughts).

What are the conclusions of the CHMP?
  • The studies in children and adolescents showed a positive effect.
  • The medicine should only be used together with psychological therapy in patients non-responding to such therapy alone after 4 to 6 sessions.
  • The starting dose should be 10 mg per day (given as 2.5ml of the oral solution) and it may be increased to 20 mg per day after one to two weeks.
  • If no clinical benefit is seen within 9 weeks, treatment should be reconsidered.
  • The significance of the observations in experimental studies on sexual development, emotional behaviour and testicular toxicity will be further investigated. The MAH will also put in place a system to obtain safety data in treated children, in particular regarding sexual development.
  • The CHMP confirmed that doctors and parents should carefully monitor children and adolescents for suicidal behaviour, particularly at the beginning of treatment.

Overall, the CHMP concluded that the benefits of Prozac are greater than its potential risks for the treatment of moderate to severe major depressive episode in children and adolescents.

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 EMA website, pending formal endorsement by the European Commission is available under the "All documents" tabs.

Name Language First published Last updated
Questions and answers on the review of Prozac for use in children and adolescents (English only) 2006-06-06  

Key facts

Approved nameProzac
International non-proprietary name (INN) or common name

Fluoxetine

Associated names
Class
Reference numberCHMP/46089/06
TypeArticle 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 is no longer applicable and has been replaced by Article 13 referrals.

StatusEuropean Commission final decision
Opinion date01/06/2006

All documents

Name Language First published Last updated
Questions and answers on the review of Prozac for use in children and adolescents (English only) 2006-06-06  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information ES = español 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information CS = čeština 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information DA = dansk 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information DE = Deutsch 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information ET = eesti keel 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information EL = elliniká 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information EN = English 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information FR = français 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information IT = italiano 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information LV = latviešu valoda 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information LT = lietuvių kalba 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information HU = magyar 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information NL = Nederlands 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information PL = polski 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information PT = português 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information SK = slovenčina 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information SL = slovenščina 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information FI = suomi 2006-08-21  
Opinion following an Article 6(12) referral for Prozac and associated names International Non-Proprietary Name (INN): Fluoxetine: Background information SV = svenska 2006-08-21  
Prozac- Article 6 (12) referral - Annex I, II, III ES = español 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III CS = čeština 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III DA = dansk 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III DE = Deutsch 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III ET = eesti keel 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III EL = elliniká 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III EN = English 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III FR = français 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III IT = italiano 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III LV = latviešu valoda 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III LT = lietuvių kalba 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III HU = magyar 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III NL = Nederlands 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III PL = polski 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III PT = português 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III SK = slovenčina 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III SL = slovenščina 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III FI = suomi 2006-09-05  
Prozac- Article 6 (12) referral - Annex I, II, III SV = svenska 2006-09-05  

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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision