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)

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Zalmoxis. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zalmoxis.

For practical information about using Zalmoxis, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 31/08/2018

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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

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

Contents

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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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