Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/01/020
Active ingredient: Ibuprofen
Indication: Treatment of patent ductus arteriosus
Sponsor: Orphan Europe S.A.R.L.
Immeuble "Le Guillaumet", 92046 Paris La Défense, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Pedea on 29/07/2004 with the number EU/1/04/284

   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
22/02/2001 Orphan designation EMEA/OD/004/00 (2001)366 of 14/02/2001
2/08/2014 Removal of orphan designation from Community Register