Overview
The marketing authorisation for Zalmoxis has been withdrawn at the request of the marketing authorisation holder.
Zalmoxis : EPAR - Summary for the public
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Product information
Zalmoxis : EPAR - Product Information
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Latest procedure affecting product information: II/0009/G
26/07/2018
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Zalmoxis : EPAR - All Authorised presentations
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svenska (SV) (577.6 KB - PDF)
Product details
- Name of medicine
- Zalmoxis
- 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
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies.
Authorisation details
- EMA product number
- EMEA/H/C/002801
Advanced therapy
This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.
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.
- Marketing authorisation holder
- MolMed SpA
Via Olgettina 58
20132 Milan
Italy - Opinion adopted
- 23/06/2016
- Marketing authorisation issued
- 18/08/2016
- Revision
- 1
Assessment history
Zalmoxis : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (650.45 KB - PDF)
News on Zalmoxis
Public statement on Zalmoxis: Withdrawal of the marketing authorisation in the European Union
English (EN) (107.2 KB - PDF)
More information on Zalmoxis
This product was originally designated an orphan medicine on 20 October 2003. Zalmoxis was withdrawn from the Community register of orphan medicinal products by the European Commission in October 2019 at the time of the withdrawal of the marketing authorisation.