Is Mesna 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 Mesna, including UROMITEXAN 400 MG, film coated tablet (400 mg, Film-coated tablet, SAR 198.60); UROMITEXAN 400MG-4ML AMP (100 mg/ml, Solution for injection, SAR 166.30); UROMITEXAN 600 MG, film coated tablet (600 mg, Film-coated tablet, SAR 280.95).

Is Mesna approved by the US FDA?

Drugs@FDA lists 12 application product lines for Mesna, including MESNEX (Prescription); MESNA (Prescription); MESNEX (Prescription); MESNA (Prescription); MESNA (Prescription).

Is Mesna on the WHO Model List of Essential Medicines?

Yes — 8.2.5. Supportive medicines (complementary list): Rhabdomyosarcoma primary site; Germ cell tumour of testis; Other specified malignant neoplasms of the ovary; Osteosarcoma of bone or articular cartilage of unspecified sites; Ewing sarcoma of bone or articular cartilage of unspecified sites; Malignant neoplasms of kidney, except renal pelvis; Burkitt lymphoma including Burkitt leukaemia.

Are there safety signals or safety updates for Mesna?

US FDA: 2 entries (latest 2018-12-17).

Active substance

Mesna

SFDA 3
US FDA 12
Health Canada 3
WHO EML 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
UROMITEXAN 400 MG, film coated tablet	400 mg	Film-coated tablet · Oral use	10 Blister	SAR 198.60	NCE · Prescription	Baxter Deutschland GmbH	Valid
UROMITEXAN 400MG-4ML AMP	100 mg/ml	Solution for injection · Intravenous use	15 Ampoule	SAR 166.30	NCE · Prescription	Baxter Deutschland GmbH	Valid
UROMITEXAN 600 MG, film coated tablet	600 mg	Film-coated tablet · Oral use	10 Blister	SAR 280.95	NCE · Prescription	Baxter Deutschland GmbH	Valid

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; BREAST CANCER EARLY HER-2 -VE -ADVERSE REACTION MANAGEMENT; BREAST CANCER HER-2 +VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET.HER-2 -VE-ADVERSE REACTION MANAGEMENT; BURKITT`S LYMPHOMA; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HODGKIN'S LYMPHOMA; MANTLE CELL LYMPHOMA; MYASTHENIA GRAVIS; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; PEDIATRIC B-CELL LYMPHOMA; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA-ADVERSE REACTION MANAGEMENT; T-CELL LYMPHOMA; WILMS TUMOR

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

Product	Strength	Form · route	Applicant	Status	First approved
MESNEX	100MG/ML	injectable · intravenous	BAXTER HLTHCARE	Prescription	30 Dec 1988
MESNA	100MG/ML	injectable · intravenous	FRESENIUS KABI USA	Prescription	26 Apr 2001
MESNEX	400MG	tablet · oral	BAXTER HLTHCARE	Prescription	21 Mar 2002
MESNA	100MG/ML	injectable · intravenous	HIKMA PHARMS	Prescription	9 Jan 2004
MESNA	1G/10ML	injectable · injection	HIKMA PHARMS	Prescription	9 Jan 2004
MESNA	100MG/ML	injectable · intravenous	SAGENT PHARMS INC	Prescription	13 Apr 2010
MESNA	100MG/ML	injectable · intravenous	GLAND	Prescription	18 Dec 2017
MESNA	400MG	tablet · oral	INGENUS PHARMS LLC	Prescription	13 Jan 2025
MESNA	100MG/ML	injectable · intravenous	EUGIA PHARMA	Prescription	27 Jan 2026
MESNA	100MG/ML	injectable · intravenous	TEVA PHARMS USA	Discontinued	27 Apr 2001
MESNA	100MG/ML	injectable · intravenous	MYLAN INSTITUTIONAL	Discontinued	8 Mar 2012
MESNA	100MG/ML	injectable · intravenous	RISING	Discontinued	18 Jul 2014

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MESNA FOR INJECTION	02244931	100 MG / ML	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
UROMITEXAN	02241411	100 MG / ML	SOLUTION · ORAL; INTRAVENOUS	BAXTER CORPORATION
UROMITEXAN	02371839	100 MG / ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION

WHO WHO Model List of Essential Medicines (2025)

8.2.5. Supportive medicines · complementary
Rhabdomyosarcoma primary site; Germ cell tumour of testis; Other specified malignant neoplasms of the ovary; Osteosarcoma of bone or articular cartilage of unspecified sites; Ewing sarcoma of bone or articular cartilage of unspecified sites; Malignant neoplasms of kidney, except renal pelvis; Burkitt lymphoma including Burkitt leukaemia
Parenteral > General injections > IV: 100 mg per mL in 4 mL ampoule; 100 mg per mL in 10 mL ampoule; 100 mg per mL in 2 mL ampoule | Oral > Solid > tablet: 400 mg; 600 mg | Oral > Other: 600 mg | Oral > Solid > tablet: 400 mg

Safety signals and safety-related labeling changes

US FDA 17 Dec 2018 MESNEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 17 Dec 2018 MESNEX — 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 mesna →

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.