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EMA Product

Enrylaze

Product approved by European Medicines Agency (EU)

Basic Information

Enrylaze

Regulatory Information

EMEA/H/C/005917

Authorised

September 15, 2023

July 20, 2023

October 5, 2023

Company Information

Ireland

Fifth Floor Waterloo Exchange Waterloo Road D04 E5W7 Dublin 4

JAZZ PHARMACEUTICALS IRELAND LIMITED

Drug Classification

Additional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic 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.

Overview Summary

Enrylaze is a cancer medicine used in adults and children aged one month and older to treat acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL), cancers of white blood cells called lymphoblasts. It is used in combination with other medicines in patients who have developed hypersensitivity (allergic reactions) or silent inactivation to E. coli-derived asparaginase, another cancer medicine. Silent inactivation means development of antibodies (proteins) that reduce the effectiveness of asparaginase without resulting in apparent allergy symptoms. Enrylaze contains the active substance crisantaspase.

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