Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

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 Bū, F-78550 Houdan, France

   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
25/09/2008 Centralised Orphan - Designation EMEA/OD/024/08 (2008)5479 of 23/09/2008
30/05/2011 Other procedure EMEA/OD/024/08
26/06/2013 Other procedure
05/08/2013 Centralised Orphan - Transfer of orphan designation EMEA/OD/024/08/T/01 (2013)5100 of 31/07/2013