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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue

EU orphan designation number: EU/3/09/667   
Active ingredient: Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue
Indication: Treatment of anal fistula
Sponsor: Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Alofisel on 23/03/2018 with the number EU/1/17/1261

   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
13/10/2009 Orphan designation EMEA/OD/054/09 (2009)7858 of 08/10/2009
04/02/2013 Change of name and/or address of sponsor
18/01/2018 Other procedure
16/05/2018 Transfer of orphan designation EMEA/OD/054/09/T/01 (2018)3029 of 08/05/2018