Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Fluoxetine
Also marketed in the EU under the name(s): Elindra, Fluctin, Fluctine, Fluoxetin, Fluoxin, Fontex, Fonzac, Ladose, Prozac
Active substance: Fluoxetine
Indication: Treatment of major depressive episodes
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
14/05/2003 Referral EMEA/H/A-30/403 (2003)1631 of 13/05/2003