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Register of orphan medicinal products


Product information

Cysteamine hydrochloride

EU orphan designation number: EU/3/08/578   
Active ingredient: Cysteamine hydrochloride
Indication: Treatment of cystinosis
Sponsor: Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Cystadrops on 19/01/2017 with the number EU/1/15/1049

   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
13/11/2008 Orphan designation EMEA/OD/036/08 (2008)6855 of 7/11/2008