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Home » HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): PHELINUN, MELPHALAN, MULTIPLE MYELOMA,HODGKIN DISEASE,LYMPHOMA, NON-HODGKIN,PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA,LEUKEMIA, MYELOID, ACUTE,NEUROBLASTOMA,OVARIAN NEOPLASMS,HEMATOPOIETIC STEM CELL TRANSPLANTATION, DATE OF AUTHORISATION: 16/11/2020, STATUS: AUTHORISED

HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): PHELINUN, MELPHALAN, MULTIPLE MYELOMA,HODGKIN DISEASE,LYMPHOMA, NON-HODGKIN,PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA,LEUKEMIA, MYELOID, ACUTE,NEUROBLASTOMA,OVARIAN NEOPLASMS,HEMATOPOIETIC STEM CELL TRANSPLANTATION, DATE OF AUTHORISATION: 16/11/2020, STATUS: AUTHORISED

(AGENPARL) – LONDON (UNITED KINGDOM), gio 26 novembre 2020

Phelinun is a cancer medicine for treating patients with:

  • cancers of the bone marrow (which produces blood cells) – multiple myeloma, acute lymphoblastic leukaemia and acute myeloid leukaemia;
  • Hodgkin and non-Hodgkin lymphomas, which are cancers that affect white blood cells called lymphocytes;
  • Childhood neuroblastoma, a cancer of nerve cells in different parts of the body;
  • ovarian cancer;
  • mammary adenocarcinoma, a type of breast cancer.

It is used either on its own or in combination with other cancer medicines, or radiotherapy or both.

Phelinun can also be used for stem cell transplantation in adults and children with blood cancers and some other blood disorders in children. It is given with other cytotoxic (cell-killing) medicines for conditioning treatment (to clear cells in the bone marrow) before the patient receives healthy stem cells from a donor to replace the diseased cells.

Phelinun contains the active substance melphalan.

Phelinun is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Phelinun is intended for an additional use (conditioning treatment). The reference medicine for Phelinun is Alkeran 50 mg/10 ml, which is marketed in France.

Fonte/Source: https://www.ema.europa.eu/en/medicines/human/EPAR/phelinun

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