Is Glucarpidase approved by the US FDA?

Drugs@FDA lists 1 application product line for Glucarpidase, including VORAXAZE (Prescription).

Is Glucarpidase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Glucarpidase: Voraxaze.

Are there safety signals or safety updates for Glucarpidase?

US FDA: 1 entry (latest 2019-08-13).

Active substance

Glucarpidase

US FDA 1
EMA 2
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VORAXAZE	1000 UNITS PER VIAL	injectable · injection	BTG INTERNATIONAL INC	Prescription	17 Jan 2012

EMA European Union — centrally authorised medicines

Voraxaze SERB SAS · Authorised · authorised 11 Jan 2022 · ATC V03AF09

Therapeutic indication (EMA)

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.

Voraxaze Protherics PLC · Application withdrawn

Safety signals and safety-related labeling changes

US FDA 13 Aug 2019 VORAXAZE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for glucarpidase →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.