HPE NICE TA552 handbook | Page 12

INSEPARABLE TOGETHER The first dual drug advanced liposomal formulation LONGER Superior overall survival vs 7+3 chemotherapy in patients with high-risk * AML *High-risk AML defined as t-AML or AML-MRC Indicated for: Treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) Please consult the Summary of Product Characteristics before prescribing Further information is available from: Jazz Pharmaceuticals Ireland, 5th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland. Legal category: POM Information about this product, including adverse reactions, precautions, contra-indcations and method of use can be found at: www.ema.europa.eu/en/medicines/human/EPAR/vyxeos www.vyxeos.eu For country specific information please refer to your local SmPC or Product Monograph Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via their national reporting system. Adverse events should also be reported by email: [email protected] or by fax to +44 (0) 1865 598765. AML: acute myeloid leukaemia AML-MRC: AML with myelodysplasia-related changes t-AML: therapy-related AML Date of preparation: April 2019 EURW-INTVYX-0026o