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Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/08/556   
Active ingredient: N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide
Indication: Treatment of cystic fibrosis
Sponsor: Vertex Pharmaceuticals (Ireland) Limited
28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Kalydeco on 23/07/2012 with the number EU/1/12/782

   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
10/07/2008 Orphan designation EMEA/OD/010/08 (2008)3593 of 8/07/2008
2/09/2011 Transfer of orphan designation EMEA/OD/010/08/T/01 (2011)6289 of 30/08/2011
13/06/2012 Other procedure
19/07/2012 Change of name and/or address of sponsor EMEA/OD/010/08
12/08/2015 Transfer of orphan designation EMA/OD/010/08/T/02 (2015)5784 of 10/08/2015
21/11/2018 Transfer of orphan designation EMA/OD/010/08/T/03 (2018)7814 of 19/11/2018