Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/16/1625   
Active ingredient: Acalabrutinib
Indication: Treatment of mantle cell lymphoma
Sponsor: Acerta Pharma, BV
Kloosterstraat 9, 5349 AB Oss, 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
25/03/2016 Orphan designation EMA/OD/231/15 (2016)1861 of 21/03/2016
21/06/2016 Change of name and/or address of sponsor