Zalmoxis

RSS

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)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Zalmoxis has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 14/02/2020

Authorisation details

Product details
Name
Zalmoxis
Agency product number
EMEA/H/C/002801
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)
International non-proprietary name (INN) or common name
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)
Therapeutic area (MeSH)
  • Hematopoietic Stem Cell Transplantation
  • Graft vs Host Disease
Anatomical therapeutic chemical (ATC) code
L01
Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
MolMed SpA
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
18/08/2016
Contact address
Via Olgettina 58
20132 Milan
Italy

Product information

26/07/2018 Zalmoxis - EMEA/H/C/002801 - II/0009/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies.

Assessment history

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