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

On June 28, 2018, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vyxeos, intended for the treatment of acute myeloid leukemia (AML). Vyxeos was designated as an orphan medicinal product o...

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Vydáno v:Oncologist
Hlavní autoři: Tzogani, Kyriaki, Penttilä, Karri, Lapveteläinen, Tuomo, Hemmings, Robert, Koenig, Janet, Freire, João, Márcia, Silva, Cole, Susan, Coppola, Paola, Flores, Beatriz, Barbachano, Yolanda, Roige, Silvia Domingo, Pignatti, Francesco
Médium: Artigo
Jazyk:Inglês
Vydáno: John Wiley & Sons, Inc. 2020
Témata:
Regulatory Issues: EMA
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC7485353/
https://ncbi.nlm.nih.gov/pubmed/32282100
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2019-0785
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