Is Melphalan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Melphalan, including ALKERAN TABLETS 2 MG (2 mg, Film-coated tablet, SAR 277.70); Megval 50 mg per 10 ml (5 mg/ml, Powder and solvent for solution for infusion, SAR 416.50); Melphalan Hydrochloride TBM (50 mg, powder for solution for injection, SAR 291.55).

Is Melphalan approved by the US FDA?

Drugs@FDA lists 24 application product lines for Melphalan, including MELPHALAN HYDROCHLORIDE (Prescription); MELPHALAN HYDROCHLORIDE (Prescription); EVOMELA (Prescription); MELPHALAN HYDROCHLORIDE (Prescription); MELPHALAN HYDROCHLORIDE (Prescription).

Is Melphalan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Melphalan: Phelinun.

Is Melphalan on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Plasma cell myeloma.

Are there safety signals or safety updates for Melphalan?

US FDA: 1 entry (latest 2021-08-09).

Active substance

Melphalan

SFDA 6
US FDA 24
EMA 1
Health Canada 1
WHO EML 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALKERAN TABLETS 2 MG	2 mg	Film-coated tablet · Oral use	25 Blister	SAR 277.70	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Valid
Megval 50 mg per 10 ml	5 mg/ml	Powder and solvent for solution for infusion · Intravenous use	1 Vial	SAR 416.50	NCE · Prescription	Emcure Pharmaceuticals Ltd.	Valid
Melphalan Hydrochloride TBM	50 mg	powder for solution for injection · Intravenous use	1 Vial	SAR 291.55	NCE · Prescription	Boston Oncology Arabia	Valid
ALKERAN TABLETS 2 MG	2 mg	Film-coated tablet · Oral use	25 Tablet Container	SAR 35.40	NCE · Prescription	GLAXOWELLCOME	Withdrawn by regulatory authority · Not Marketed
ALKERAN TABLETS 2 MG	2 mg	Film-coated tablet · Oral use	25 Blister	SAR 86.55	NCE · Prescription	ASPEN	Withdrawn by MAH · Not Marketed
ALKERAN TABLETS 5 MG	5 mg	Tablet · Oral use	25 Blister	SAR 57.45	NCE · Prescription	GLAXOWELLCOME	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ALL TYPES OF LYMPHOMA; AMYLOIDOSIS - LIGHT CHAIN; MULTIPLE MYELOMA; Neuroblastoma; RETINOBLASTOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	MYLAN INSTITUTIONAL	Prescription	9 Jun 2009
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	HIKMA PHARMS	Prescription	28 Oct 2010
EVOMELA	EQ 50MG BASE/VIAL	powder · intravenous	ACROTECH BIOPHARMA	Prescription	10 Mar 2016
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	ACTAVIS LLC	Prescription	19 Dec 2016
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	SAGENT PHARMS INC	Prescription	28 Feb 2017
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	DR REDDYS	Prescription	8 Dec 2017
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	FRESENIUS KABI USA	Prescription	22 Dec 2017
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	GLAND	Prescription	28 May 2019
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	QUAGEN	Prescription	13 Sep 2019
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	BPI LABS	Prescription	8 May 2020
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	MEITHEAL	Prescription	28 May 2021
HEPZATO	EQ 50MG BASE/VIAL	powder · intra-arterial	DELCATH SYSTEMS INC	Prescription	14 Aug 2023
IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	solution · intravenous	APOTEX	Prescription	18 Aug 2023
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	HETERO LABS	Prescription	23 May 2024
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	AVET LIFESCIENCES	Prescription	29 Oct 2024
ALKERAN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	APOTEX	Discontinued	17 Jan 1964
ALKERAN	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	APOTEX	Discontinued	18 Nov 1992
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	MYLAN INSTITUTIONAL	Discontinued	27 Oct 2009
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	PH HEALTH	Discontinued	22 Aug 2016
MELPHALAN	2MG	tablet · oral	ALVOGEN	Discontinued	22 Mar 2017
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	USWM	Discontinued	3 May 2019
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	ALMAJECT	Discontinued	17 May 2019
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	injectable · injection	INGENUS PHARMS LLC	Discontinued	18 Feb 2020
MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	powder · intravenous	ACTAVIS LLC	Discontinued	6 Mar 2020

EMA European Union — centrally authorised medicines

Phelinun · Authorised · authorised 16 Nov 2020 · ATC L01AA03

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALKERAN	00004715	2 MG	TABLET · ORAL	ASPEN PHARMACARE CANADA INC.

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Plasma cell myeloma
Parenteral > General injections > IV: 50 mg in vial powder for injection | Oral > Solid: 2 mg

Safety signals and safety-related labeling changes

US FDA 9 Aug 2021 EVOMELA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for melphalan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.