Voraxaze (glucarpidase)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- glucarpidase
- Company
- SERB SAS
- Status
- Authorised
- Therapeutic area
- Metabolic Side Effects of Drugs and Substances
- CHMP opinion
- Thu 11 Nov 2021
- EU approval
- Tue 11 Jan 2022
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005467
- ATC
- V03AF09
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Voraxaze Application withdrawn · Protherics PLC
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.