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Community register of orphan medicinal products


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Product information

Monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E

EU orphan designation number: EU/3/08/596   
Active ingredient: Monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E
Indication: Treatment of Hodgkin lymphoma
Sponsor: Takeda Pharma A/S
Langebjerg 1, DK-4000 Roskilde, Danmark
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name ADCETRIS on 25/10/2012 with the number EU/1/12/794

   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
20/01/2009 Centralised Orphan - Designation EMEA/OD/073/08 (2009)190 of 15/01/2009
30/09/2010 Centralised Orphan - Transfer of orphan designation EMEA/OD/073/08/T/01 (2010)6810 of 28/09/2010
23/10/2013 Centralised Orphan - Transfer of orphan designation EMEA/OD/073/08/T/02 (2013)7104 of 21/10/2013