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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 Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Procysbi on 6/09/2013 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
11/07/2013 Other procedure
7/02/2017 Change of name and/or address of sponsor
21/11/2017 Change of name and/or address of sponsor
18/05/2018 Transfer of orphan designation EMA/OD/034/10/T/01 (2018)3137 of 16/05/2018