Pharmaceuticals - Union Register

  

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 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
24/06/2015 Orphan designation EMA/OD/013/15 (2015)4323 of 19/06/2015
13/02/2018 Transfer of orphan designation EMA/OD/013/15/T/01 (2018)943 of 9/02/2018