Zalmoxis
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)
Table of contents
Overview
The marketing authorisation for Zalmoxis has been withdrawn at the request of the marketing authorisation holder.
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) |
|
| Anatomical therapeutic chemical (ATC) code |
L01
|
Conditional 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
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.