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Register of orphan medicinal products


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Product information

Autologous CD34+ cells transduced with lentiviral vector encoding the human beta globin gene

EU orphan designation number: EU/3/16/1660   
Active ingredient: Autologous CD34+ cells transduced with lentiviral vector encoding the human beta globin gene
Indication: Treatment of beta thalassaemia intermedia and major
Sponsor: Orchard Therapeutics (Europe) Limited
108 Cannon Street, London EC4N 6EU, United Kingdom

   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
1/06/2016 Orphan designation EMA/OD/024/16 (2016)3415 of 30/05/2016
7/09/2017 Transfer of orphan designation EMA/OD/024/16/T/01 (2017)6104 of 5/09/2017
2/08/2018 Transfer of orphan designation EMA/OD/024/16/T/02 (2018)5288 of 31/07/2018
11/03/2019 Change of name and/or address of sponsor