Table of contents
Voraxaze is a medicine used to lower the level of methotrexate (a cancer medicine) in the blood of adults and children older than 28 days whose body is not able to remove methotrexate quickly enough or who are at risk of methotrexate toxicity (when methotrexate is harmful to normal cells and organs in the body).
Methotrexate toxicity is rare, and Voraxaze was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 3 February 2003.
Voraxaze contains the active substance glucarpidase.
Voraxaze : EPAR - Medicine Overview (PDF/144.24 KB)
First published: 20/01/2022
Voraxaze : EPAR - Risk management plan summary (PDF/158.34 KB)
First published: 20/01/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Metabolic Side Effects of Drugs and Substances
|Anatomical therapeutic chemical (ATC) code||
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.
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.
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.
|Date of issue of marketing authorisation valid throughout the European Union||
40 Avenue George V
Voraxaze - EMEA/H/C/005467 -
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).
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.
All other therapeutic products
Voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.