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Register of orphan medicinal products


Product information

Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate

EU orphan designation number: EU/3/07/518   
Active ingredient: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate
Indication: Treatment of pulmonary arterial hypertension including treatment of chronic thromboembolic pulmonary hypertension
Sponsor: Bayer AG
D-51368 Leverkusen, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Adempas on 27/03/2014 with the number EU/1/13/907

   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
27/12/2007 Orphan designation EMEA/OD/088/07 (2007)6809 of 20/12/2007
8/04/2009 Transfer of orphan designation EMEA/OD/088/07/T/01 (2009)2731 of 3/04/2009
17/10/2011 Change of name and/or address of sponsor
30/08/2017 Transfer of orphan designation EMEA/OD/088/07/T/02 (2017)5980 of 28/08/2017