Navigation path

Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

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

EU orphan designation number: EU/3/08/595   
Active ingredient: Monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E
Indication: Treatment of anaplastic large cell lymphoma
Sponsor: Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, 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 Orphan designation EMEA/OD/072/08 (2009)189 of 15/01/2009
30/09/2010 Transfer of orphan designation EMEA/OD/072/08/T/01 (2010)6809 of 28/09/2010
05/09/2012 Other procedure
23/10/2013 Transfer of orphan designation EMEA/OD/072/08/T/02 (2013)7103 of 21/10/2013
26/03/2015 Change of name and/or address of sponsor