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Register of orphan medicinal products


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Product information

Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a COL7A1-encoding retroviral vector

EU orphan designation number: EU/3/15/1466   
Active ingredient: Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a COL7A1-encoding retroviral vector
Indication: Treatment of epidermolysis bullosa
Sponsor: Holostem Terapie Avanzate S.r.l.
Via Glauco Gottardi 100, Modena, MO 41125, Italia

   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
23/03/2015 Orphan designation EMA/OD/298/14 (2015)2035 of 19/03/2015
28/03/2019 Transfer of orphan designation EMA/OD/0000004603 (2019)2413 of 25/03/2019