Overview

The marketing authorisation for Zalmoxis has been withdrawn at the request of the marketing authorisation holder.

Zalmoxis : EPAR - Summary for the public

български (BG) (760.89 KB - PDF)
español (ES) (653.89 KB - PDF)
čeština (CS) (733.96 KB - PDF)
dansk (DA) (653.11 KB - PDF)
Deutsch (DE) (655.77 KB - PDF)
eesti keel (ET) (650.21 KB - PDF)
ελληνικά (EL) (765.42 KB - PDF)
français (FR) (655.08 KB - PDF)
hrvatski (HR) (664.62 KB - PDF)
italiano (IT) (652.81 KB - PDF)
latviešu valoda (LV) (715.93 KB - PDF)
lietuvių kalba (LT) (669.25 KB - PDF)
magyar (HU) (727.73 KB - PDF)
Malti (MT) (717.66 KB - PDF)
Nederlands (NL) (653.86 KB - PDF)
polski (PL) (733.21 KB - PDF)
português (PT) (653.34 KB - PDF)
română (RO) (668.59 KB - PDF)
slovenčina (SK) (732.91 KB - PDF)
slovenščina (SL) (726.58 KB - PDF)
Suomi (FI) (652.21 KB - PDF)
svenska (SV) (651.83 KB - PDF)

Product information

Zalmoxis : EPAR - Product Information

български (BG) (1.71 MB - PDF)
español (ES) (1.04 MB - PDF)
čeština (CS) (1.62 MB - PDF)
dansk (DA) (856.94 KB - PDF)
Deutsch (DE) (939.53 KB - PDF)
eesti keel (ET) (1.05 MB - PDF)
ελληνικά (EL) (1.86 MB - PDF)
français (FR) (1.06 MB - PDF)
hrvatski (HR) (1.19 MB - PDF)
íslenska (IS) (1.03 MB - PDF)
italiano (IT) (1.09 MB - PDF)
latviešu valoda (LV) (1.64 MB - PDF)
lietuvių kalba (LT) (1.12 MB - PDF)
magyar (HU) (1.62 MB - PDF)
Malti (MT) (1.65 MB - PDF)
Nederlands (NL) (1004.44 KB - PDF)
norsk (NO) (1.08 MB - PDF)
polski (PL) (1.63 MB - PDF)
português (PT) (1.04 MB - PDF)
română (RO) (1.12 MB - PDF)
slovenčina (SK) (1.62 MB - PDF)
slovenščina (SL) (1.64 MB - PDF)
Suomi (FI) (1.16 MB - PDF)
svenska (SV) (913.58 KB - PDF)

Latest procedure affecting product information: II/0009/G

26/07/2018

Globe icon

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

български (BG) (620.06 KB - PDF)
español (ES) (577.71 KB - PDF)
čeština (CS) (608.26 KB - PDF)
dansk (DA) (577.54 KB - PDF)
Deutsch (DE) (577.51 KB - PDF)
eesti keel (ET) (577.67 KB - PDF)
ελληνικά (EL) (619.96 KB - PDF)
français (FR) (577.52 KB - PDF)
hrvatski (HR) (591.71 KB - PDF)
íslenska (IS) (577.59 KB - PDF)
italiano (IT) (577.7 KB - PDF)
latviešu valoda (LV) (610.12 KB - PDF)
lietuvių kalba (LT) (594.87 KB - PDF)
magyar (HU) (599.51 KB - PDF)
Malti (MT) (611.06 KB - PDF)
Nederlands (NL) (577.31 KB - PDF)
norsk (NO) (577.68 KB - PDF)
polski (PL) (609.04 KB - PDF)
português (PT) (577.7 KB - PDF)
română (RO) (592.97 KB - PDF)
slovenčina (SK) (600.14 KB - PDF)
slovenščina (SL) (605.32 KB - PDF)
Suomi (FI) (577.43 KB - PDF)
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 agents

Therapeutic 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

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

Zalmoxis : EPAR - Public assessment report

CHMP summary of opinion for Zalmoxis

This page was last updated on

How useful do you find this page?