Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Para-aminosalicylic acid

EU orphan designation number: EU/3/10/826   
Active ingredient: Para-aminosalicylic acid
Indication: Treatment of tuberculosis
Sponsor: Lucane Pharma SA
172 rue de Charonne, 75011 Paris, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Granupas on 07/04/2014 with the number EU/1/13/896

   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
21/12/2010 Centralised Orphan - Designation EMA/OD/072/10 (2010)9539 of 17/12/2010
17/02/2012 Centralised Orphan - Transfer of orphan designation EMEA/OD/072/10/T/01 (2012)1109 of 15/02/2012
28/08/2013 Other procedure