Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/05/325   
Active ingredient: Mannitolum
Indication: Treatment of cystic fibrosis
Sponsor: Pharmaxis Pharmaceuticals Limited
25 Moorgate, London, EC2R 6AY, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Bronchitol on 13/04/2012 with the number EU/1/12/760

   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
09/11/2005 Orphan designation EMEA/OD/062/05 (2005)4383 of 07/11/2005
13/10/2006 Transfer of orphan designation EMEA/OD/062/05/T/01 (2006)4898 of 11/10/2006
18/02/2008 Change of name and/or address of sponsor
22/06/2010 Change of name and/or address of sponsor EMEA/OD/062/05
07/12/2011 Other procedure
03/11/2016 Change of name and/or address of sponsor EMA/OD/062/05