Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

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 Orphan designation EMA/OD/072/10 (2010)9539 of 17/12/2010
17/02/2012 Transfer of orphan designation EMA/OD/072/10/T/01 (2012)1109 of 15/02/2012
28/08/2013 Change of name and/or address of sponsor