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Register of orphan medicinal products


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Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1

EU orphan designation number: EU/3/18/2112   
Active ingredient: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1
Indication: Treatment of biliary tract cancer
Sponsor: Merck Europe B.V.
Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland

  

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Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/12/2018 Orphan designation EMA/OD/154/18 (2018)9027 of 14/12/2018