🇪🇺 Erwinase in European Union

EMA authorised Erwinase on 15 September 2023

Marketing authorisation

EMA — authorised 15 September 2023

  • Application: EMEA/H/C/005917
  • Marketing authorisation holder: Jazz Pharmaceuticals Ireland Limited
  • Local brand name: Enrylaze
  • Indication: Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
  • Status: approved

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Erwinase in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is Erwinase approved in European Union?

Yes. EMA authorised it on 15 September 2023.

Who is the marketing authorisation holder for Erwinase in European Union?

Jazz Pharmaceuticals Ireland Limited holds the EU marketing authorisation.