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Phelinun (melphalan)

Region

🇪🇺 EU

Active substance

melphalan

Status

Authorised

Therapeutic area

Multiple Myeloma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Neuroblastoma; Ovarian Neoplasms; Hematopoietic Stem Cell Transplantation

CHMP opinion

Thu 17 Sep 2020

EU approval

Mon 16 Nov 2020

Application

EMEA/H/C/005173

ATC

L01AA03

Official record

www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Pepaxti Authorised · Oncopeptides AB (publ)

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.