Melphalan
Nitrogen Mustard Analogues
Sold as Phelinun · ALKERAN
- Drug class
- Nitrogen Mustard Analogues
- Availability
- See label
- Routes
- Intravenous, Intra-Arterial, Oral
- Markets covered
- 3
- Products on record
- 22
Overview
Melphalan is an active pharmaceutical ingredient in the Nitrogen Mustard Analogues group (L01AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 14 | May 15, 2026 |
| CA Canada | Health Canada | 7 | April 10, 2026 |
| EU European Union | EMA | 1 | June 18, 2025 |
GBUnited Kingdom· MHRA
14 products
Uses
Melphalan Injection, at conventional intravenous dose, is indicated in the treatment of multiple myeloma and ovarian cancer. Melphalan Injection, at high intravenous dosage, is indicated, with or without haematopoietic stem cell transplantation, for the treatment of multiple myeloma and childhood neuroblastoma.
In the above indications, Melphalan Injection may be used alone or in combination with other cytotoxic medicinal products.
How to take
CACanada· Health Canada
7 products
Uses
TARO-MELPHALAN (melphalan) is indicated for: • the palliative treatment of multiple myeloma • the palliation of nonresectable epithelial carcinoma of the ovary. • TARO-MELPHALAN for injection has been administered by hyperthermic isolated limb perfusion as an adjuvant to surgery in the treatment of malignant melanoma.
However, there have been no prospective controlled or uncontrolled trials evaluating dose and its relationship to disease response and/or toxicity. 1 Pediatrics Pediatrics (<18 years): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (> 65 years): TARO-MELPHALAN is approved for use in the geriatric population. 4 Geriatrics).
EUEuropean Union· EMA
1 product
Uses
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, 3 - 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.
Drug interactions
Known interactions involving Melphalan. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL001421285 · revised May 15, 2026
- [2]Health Canada (DPD) · 02480026 · revised April 10, 2026
- [3]European Medicines Agency · EMEA/H/C/005173 · revised June 18, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.