Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Hydroxyurea

EU orphan designation number: EU/3/03/154   
Active ingredient: Hydroxyurea
Indication: Treatment of sickle cell syndrome
Sponsor: Addmedica SAS
101 rue Saint Lazare, F-75009 Paris, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Siklos on 29/06/2007 with the number EU/1/07/397

   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
15/07/2003 Orphan designation EMEA/OD/013/03 (2003)2571 of 09/07/2003
19/10/2006 Transfer of orphan designation EMEA/OD/013/03/T/01 (2006)5014 of 17/10/2006
28/09/2016 Change of name and/or address of sponsor