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Community register of orphan medicinal products


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Product information

Autologous CD34+ cells transfected with retroviral vector containing adenosine deaminase gene

EU orphan designation number: EU/3/05/313   
Active ingredient: Autologous CD34+ cells transfected with retroviral vector containing adenosine deaminase gene
Indication: Treatment of severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) deficiency
Sponsor: GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Strimvelis on with the number EU/1/16/1097

   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
31/08/2005 Orphan designation EMEA/OD/053/05 (2005)3357 of 26/08/2005
02/12/2009 Change of name and/or address of sponsor
24/06/2011 Transfer of orphan designation EMEA/OD/053/05/T/01 (2011)4557 of 21/06/2011
04/02/2014 Change of name and/or address of sponsor
01/08/2014 Transfer of orphan designation EMA/OD/053/05/T/02 (2014)5573 of 30/07/2014