Title:

European Medicines Agency (EMEA) Adopts a Positive Opinion for the use of Prozac in Children of 8 Years and Older.

Date:

7th June 2006

Author:

Susan Wileman Medicines Information Technician

 

Source – European Medicines Agency (EMEA) - The European Medicines Agency (EMEA) has recommended to extend the indication for Prozac (fluoxetine) and associated names to include the treatment of children of 8 years of age and over who suffer from moderate to severe depression and who do not respond to psychological therapy.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benfits of using Prozac for this indication outweigh its potential risks. The Committee has asked the authorisation holder Eli Lilly, to carry out additional studies to ensure that the safety profile of Prozac remains acceptable.

For more information go to: http://www.emea.eu.int/pdfs/human/press/pr/20255406en.pdf

Prepared by Susan Wileman Medicines Information Technician

Date of Preparation: 7th June 2006