Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Levofloxacin hemihydrate

EU orphan designation number: EU/3/08/566
Active ingredient: Levofloxacin hemihydrate
Indication: Treatment of cystic fibrosis
Sponsor: Aptalis Pharma SAS
Route de Bû, F-78550 Houdan, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Quinsair on 26/03/2015 with the number EU/1/14/973

   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
25/09/2008 Orphan Designation EMEA/OD/024/08 (2008)5479 of 23/09/2008
30/05/2011 Change of address of sponsor EMEA/OD/024/08
26/06/2013 Change of address of sponsor
05/08/2013 Transfer of orphan designation EMEA/OD/024/08/T/01 (2013)5100 of 31/07/2013
18/02/2015 Removal of orphan designation from Community Register