Enrylaze (crisantaspase)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- crisantaspase
- Company
- Jazz Pharmaceuticals Ireland Limited
- Status
- Authorised
- Therapeutic area
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Fri 15 Sep 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005917
- ATC
- L01XX02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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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.