Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/12/1054   
Active ingredient: Obinutuzumab
Indication: Treatment of chronic lymphocytic leukaemia
Sponsor: Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
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
12/10/2012 Orphan designation EMA/OD/102/12 (2012)7231 of 10/10/2012
12/06/2014 Other procedure
13/02/2018 Transfer of orphan designation EMA/OD/102/12/T/01 (2018)940 of 09/02/2018