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Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor

EU orphan designation number: EU/3/18/2116   
Active ingredient: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor
Indication: Treatment of cystic fibrosis
Sponsor: Vertex Pharmaceuticals (Ireland) Limited
Fitzwilliam House, 28-32 Pembroke Street Upper, Dublin 2, Co. Dublin, D02 EK84, Ireland

  

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/12/2018 Orphan designation EMA/OD/139/18 (2018)9031 of 14/12/2018
18/02/2019 Transfer of orphan designation EMA/OD/0000003732 (2019)1362 of 12/02/2019