This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 20/01/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Metabolic Side Effects of Drugs and Substances
Anatomical therapeutic chemical (ATC) code
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.

Exceptional circumstancesExceptional circumstances

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.

Publication details
Marketing-authorisation holder
Date of issue of marketing authorisation valid throughout the European Union
Contact address
40 Avenue George V
75008 Paris

Product information

Voraxaze - EMEA/H/C/005467 -

Other EU languages available 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:

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

All other therapeutic products

Therapeutic indication

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.

Assessment history

Related content

How useful was this page?

Add your rating