Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/06/360   
Active ingredient: Ciclosporin
Indication: Treatment of vernal keratoconjunctivitis
Sponsor: Santen Oy
Niittyhaankatu 20, 33720 Tampere, Suomi
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Verkazia on 10/07/2018 with the number EU/1/17/1219

   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
12/04/2006 Orphan designation EMEA/OD/106/05 (2006)1573 of 6/04/2006
26/03/2015 Change of name and/or address of sponsor
19/01/2016 Transfer of orphan designation EMA/OD/106/05/T/01 (2016)252 of 15/01/2016
31/05/2018 Other procedure