Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/08/581   
Active ingredient: Ofatumumab
Indication: Treatment of chronic lymphocytic leukaemia
Sponsor: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Arzerra on 19/04/2010 with the number EU/1/10/625

   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
11/11/2008 Orphan Designation EMEA/OD/051/08 (2008)6859 of 07/11/2008
04/02/2014 Change of address of sponsor