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Community register of orphan medicinal products


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Product information

Recombinant human tissue non-specific alkaline phosphatase - Fc - deca-aspartate fusion protein

EU orphan designation number: EU/3/08/594   
Active ingredient: Recombinant human tissue non-specific alkaline phosphatase - Fc - deca-aspartate fusion protein
Indication: Treatment of hypophosphatasia
Sponsor: Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Strensiq on 28/08/2015 with the number EU/1/15/1015

   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
08/12/2008 Orphan designation EMEA/OD/071/08 (2008)8090 of 03/12/2008
05/10/2010 Transfer of orphan designation EMEA/OD/071/08/T/01 (2010)6808 of 28/09/2010
01/06/2011 Corrigendum (2011)3906 of 30/05/2011
19/09/2012 Transfer of orphan designation EMEA/OD/071/08/T/02 (2012)6515 of 14/09/2012
20/02/2015 Change of name and/or address of sponsor