Phelinun

RSS

melphalan

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 24/06/2021

Authorisation details

Product details
Name
Phelinun
Agency product number
EMEA/H/C/005173
Active substance
melphalan hydrochloride
International non-proprietary name (INN) or common name
melphalan
Therapeutic area (MeSH)
  • Multiple Myeloma
  • Hodgkin Disease
  • Lymphoma, Non-Hodgkin
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Neuroblastoma
  • Ovarian Neoplasms
  • Hematopoietic Stem Cell Transplantation
Anatomical therapeutic chemical (ATC) code
L01AA03
Publication details
Marketing-authorisation holder
ADIENNE S.r.l. S.U.
Date of issue of marketing authorisation valid throughout the European Union
16/11/2020
Contact address

Via Galileo Galilei, 19
20867 Caponago (MB)
Italy

Product information

16/11/2020 Phelinun - EMEA/H/C/005173 -

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:

  • multiple myeloma,
  • malignant lymphoma (Hodgkin, non-Hodgkin lymphoma),
  • acute lymphoblastic and myeloblastic leukemia,
  • childhood neuroblastoma,
  • ovarian cancer,
  • mammary adenocarcinoma.

Phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults.

Phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:

  • Myeloablative conditioning (MAC) treatment in case of malignant haematological diseases
  • RIC treatment in case of non-malignant haematological diseases.

Assessment history

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