Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Obinutuzumab

EU orphan designation number: EU/3/15/1504   
Active ingredient: Obinutuzumab
Indication: Treatment of follicular lymphoma
Sponsor: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Gazyvaro on 23/07/2014 with the number EU/1/14/937

   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
24/06/2015 Orphan designation EMA/OD/013/15 (2015)4323 of 19/06/2015