Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Topamax
Also marketed in the EU under the name(s): Epitomax, Topamac, Topimax, Topiramat
Active substance: topiramate
Indication: Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options.
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
05/10/2009 Referral EMEA/H/A-30/999 (2009)7662 of 01/10/2009
31/01/2011 Corrigendum (2009)7662 of 27/01/2011
06/03/2012 Corrigendum (2009)7662 of 02/03/2012