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- (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifl
Pharmaceuticals - Community Register
Community register of orphan medicinal products | GRANTED |
Product information |
(S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester
| EU orphan designation number: | EU/3/17/1861
|
| Active ingredient: | (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester |
| Indication: | Treatment of pulmonary arterial hypertension |
| Sponsor: | Biological Consulting Europe Ltd
Wallace Building, Roslin BioCentre, Roslin, Midlothian, EH25 9PP, United Kingdom |
Public summary of scientific opinion
European Commission procedures |
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 22/04/2017 | Orphan designation | EMA/OD/299/16 | (2017)2780 of 20/04/2017 |
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