EMA — authorised 31 December 2009
- Application: EMEA/H/C/000681
- Marketing authorisation holder: Protherics PLC
- Local brand name: Voraxaze
- Pathway: orphan
- Status: withdrawn
🇪🇺 Voraxaze in European Union
EMA authorised Voraxaze on 31 December 2009
Marketing authorisations
EMA — authorised 11 January 2022
- Marketing authorisation holder: SERB SAS
- Status: approved
EMA — authorised 11 January 2022
- Application: EMEA/H/C/005467
- Marketing authorisation holder: SERB SAS
- Local brand name: Voraxaze
- 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.
- Pathway: exceptional circumstances, orphan
- Status: approved
Voraxaze in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Voraxaze approved in European Union?
Yes. EMA authorised it on 31 December 2009; EMA authorised it on 11 January 2022; EMA authorised it on 11 January 2022.
Who is the marketing authorisation holder for Voraxaze in European Union?
Protherics PLC holds the EU marketing authorisation.