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: Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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 7/11/2008
4/02/2014 Change of name and/or address of sponsor
19/05/2015 Transfer of orphan designation EMA/OD/051/08/T/01 (2015)3436 of 13/05/2015
1/10/2018 Transfer of orphan designation EMA/OD/051/08/T/02 (2018)6418 of 27/09/2018