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Community register of orphan medicinal products


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Product information

Recombinant human monoclonal antibody against hepatitis B virus

EU orphan designation number: EU/3/13/1156   
Active ingredient: Recombinant human monoclonal antibody against hepatitis B virus
Indication: Prevention of hepatitis B re-infection following liver transplantation
Sponsor: inVentiv Health Germany GmbH
Frankfurter Str. 233, Triforum, Haus C, 63263 Neu-Isenburg, Deutschland

   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
19/07/2013 Orphan Designation EMA/OD/045/13 (2013)4730 of 17/07/2013
01/08/2014 Transfer of orphan designation EMA/OD/045/13/T/01 (2014)5577 of 30/07/2014