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Community register of orphan medicinal products


Product information

Chimeric monoclonal antibody against GD2

EU orphan designation number: EU/3/12/1062   
Active ingredient: Chimeric monoclonal antibody against GD2
Indication: Treatment of neuroblastoma
Sponsor: EUSA Pharma (UK) Limited
Breakspear Park, Breakspear Way, Hemel Hempstead HP2 4TZ, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Dinutuximab beta Apeiron on 08/05/2017 with the number EU/1/17/1191

   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
12/11/2012 Orphan designation EMA/OD/112/12 (2012)8195 of 08/11/2012
07/09/2017 Transfer of orphan designation EMA/OD/112/12/T/01 (2017)6104 of 05/09/2017