Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/10/764   
Active ingredient: Everolimus
Indication: Treatment of tuberous sclerosis
Sponsor: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Votubia on 02/09/2011 with the number EU/1/11/710

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
06/08/2010 Orphan designation EMA/OD/010/10 (2010)5531 of 04/08/2010
29/08/2014 Change of name and/or address of sponsor