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Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Recombinant human monoclonal IgG1 antibody against programmed death ligand-1

EU orphan designation number: EU/3/15/1590   
Active ingredient: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1
Indication: Treatment of Merkel cell carcinoma
Sponsor: Merck Europe B.V.
Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Bavencio on 18/09/2017 with the number EU/1/17/1214

   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
16/12/2015 Orphan designation EMA/OD/150/15 (2015)9511 of 14/12/2015
22/08/2016 Transfer of orphan designation EMA/OD/150/15/T/01 (2016)5451 of 18/08/2016
27/06/2018 Transfer of orphan designation EMA/OD/150/15/T/02 (2018)4088 of 25/06/2018