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Community register of orphan medicinal products


Product information

Cysteamine bitartrate (gastroresistant)

EU orphan designation number: EU/3/10/778   
Active ingredient: Cysteamine bitartrate (gastroresistant)
Indication: Treatment of cystinosis
Sponsor: Chiesi Orphan Europe B.V.
Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Procysbi on 06/09/2013 with the number EU/1/13/861

   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
22/09/2010 Orphan designation EMA/OD/034/10 (2010)6645 of 20/09/2010
07/02/2017 Change of name and/or address of sponsor
21/11/2017 Change of name and/or address of sponsor