Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Gemtuzumab Ozogamicin

EU orphan designation number: EU/3/00/005   
Active ingredient: Gemtuzumab Ozogamicin
Indication: Treatment of acute myeloid leukaemia
Sponsor: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

   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
13/11/2000 Orphan Designation EMEA/OD/022/00 (2000)3025 of 18/10/2000
10/10/2005 Change of address of sponsor
05/03/2013 Change of address of sponsor
19/03/2013 Transfer of orphan designation EMEA/OD/022/00/T/01 (2013)1711 of 15/03/2013