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Pharmaceuticals - Union Register


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: Eurocept International B.V.
Trapgans 5, 1244 RL Ankeveen, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Granupas on 7/04/2014 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
29/05/2018 Transfer of orphan designation EMA/OD/072/10/T/02 (2018)3396 of 25/05/2018