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Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/15/1498   
Active ingredient: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl)acetamide
Indication: Treatment of cystic fibrosis
Sponsor: Clinical Network Services (NL) B.V.
De Cuserstraat 93, 1081 CN Amsterdam, Noord-Holland, Nederland

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
26/05/2015 Orphan designation EMA/OD/018/15 (2015)3578 of 21/05/2015
19/12/2017 Change of name and/or address of sponsor
4/02/2019 Transfer of orphan designation EMA/OD/0000003040 (2019)815 of 30/01/2019