Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zalmoxis   
Auth. number : EU/1/16/1121
Active substance : Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)
Orphan market exclusivity for "Adjunctive treatment in hematopoietic cell transplantation" (based on designation EU/3/03/168) started on 23/08/2016
   10 years of market exclusivity
   This orphan market exclusivity will expire on 23/08/2026
ATC: Pending
Indication: Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies.
Marketing Authorisation Holder: MolMed S.p.A.
Via Olgettina 58, 20132 Milano, Italia
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/08/2016 Centralised - Authorisation EMEA/H/C/2801 (2016)5445 of 18/08/2016
17/07/2017 Centralised - Annual renewal EMEA/H/C/2801/R/3 (2017) 5100 of 13/07/2017
7/11/2017 Corrigendum (2016)5445 of 18/08/2016
26/07/2018 Centralised - Variation EMEA/H/C/2801/II/9/G
30/07/2018 Centralised - Annual renewal EMEA/H/C/2801/R/10 (2018)5118 of 26/07/2018