Navigation path

Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Chimeric monoclonal antibody against GD2

EU orphan designation number: EU/3/11/879   
Active ingredient: Chimeric monoclonal antibody against GD2
Indication: Treatment of neuroblastoma
Sponsor: United Therapeutics Europe Ltd
Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Unituxin on 14/08/2015 with the number EU/1/15/1022

   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
24/06/2011 Orphan designation EMA/OD/002/11 (2011)4553 of 21/06/2011