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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


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Product information

Antisense oligonucleotide targeted to the SMN2 gene

EU orphan designation number: EU/3/12/976   
Active ingredient: Antisense oligonucleotide targeted to the SMN2 gene
Indication: Treatment of 5q spinal muscular atrophy
Sponsor: Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Spinraza on 30/05/2017 with the number EU/1/17/1188

   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
04/04/2012 Orphan designation EMA/OD/141/11 (2012)2346 of 02/04/2012
07/04/2016 Change of name and/or address of sponsor
22/08/2016 Transfer of orphan designation EMA/OD/141/11/T/01 (2016)5453 of 18/08/2016