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Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA

EU orphan designation number: EU/3/11/857   
Active ingredient: Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA
Indication: Treatment of transthyretin-mediated amyloidosis
Sponsor: Alnylam Netherlands B.V.
Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Onpattro on 27/08/2018 with the number EU/1/18/1320

   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
19/04/2011 Orphan designation EMA/OD/142/10 (2011)2844 of 15/04/2011
13/11/2014 Transfer of orphan designation EMA/OD/142/10/T/01 (2014)8536 of 11/11/2014
10/04/2017 Amendment of orphan designation EMA/OD/142/10 (2017)2424 of 6/04/2017
11/10/2017 Change of name and/or address of sponsor
29/05/2018 Transfer of orphan designation EMA/OD/142/10/T/02 (2018)3398 of 25/05/2018
30/07/2018 Other procedure