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Community register of orphan medicinal products


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Product information

Humanised monoclonal modified IgG4 antibody with bispecific structure targeting factors IX, IXa, X and Xa

EU orphan designation number: EU/3/13/1221   
Active ingredient: Humanised monoclonal modified IgG4 antibody with bispecific structure targeting factors IX, IXa, X and Xa
Indication: Treatment of haemophilia A
Sponsor: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

   Public summary of scientific opinion    

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/01/2014 Centralised Orphan - Designation EMA/OD/144/13 (2013)9709 of 18/12/2013
08/12/2014 Centralised Orphan - Transfer of orphan designation EMA/OD/144/13/T/01 (2014)9379 of 03/12/2014