PHELINUN® 50 and 200 mg vials
has been granted marketing authorization by EMA, intended for the treatment of certain haematological and other cancers and as reduced intensity conditioning treatment prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in adults and children.
The full indications are :
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 treatment prior to allogeneic haematopoietic stem cell transplantation 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:
The active substance of PHELINUN®
is melphalan hydrochloride, an anti-neoplastic agent (ATC code: L01AA03) which prevents the separation and replication of DNA, thereby preventing cell replication.
PHELINUN® is actually available as 50-mg and 200-mg powder and solvent for concentrate for solution for infusion.