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EMA Review of Daunorubicin and Cytarabine Encapsulated in Liposomes (Vyxeos,CPX-351) for the Treatment of Adults with Newly Diagnosed,Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes |
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| Authors: | Kyriaki Tzogani Karri Penttilä Tuomo Lapveteläinen Robert Hemmings Janet Koenig João Freire Silva Márcia Susan Cole Paola Coppola Beatriz Flores Yolanda Barbachano Silvia Domingo Roige Francesco Pignatti |
| Affiliation: | 1. European Medicines Agency, Amsterdam, The Netherlands;2. Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands Finnish Medicines Agency, Fimea, Finland;3. Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands Medicines and Healthcare Products Regulatory Agency, London, United Kingdom;4. Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands Federal Institute for Drugs and Medical Devices, Bonn, Germany;5. Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands INFARMED, IP, Lisboa, Portugal |
| Abstract: | |
| Keywords: | Vyxeos (cytarabine and daunorubicin) Therapy-related acute myeloid leukemia Acute myeloid leukemia with myelodysplasia-related changes European Medicines Agency |