Active substance
Ifosfamide
- SFDA 3
- US FDA 6
- Health Canada 2
- WHO EML 1
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| HOLOXAN 1GM I.V. VIAL | 1 g | Powder for injection · Intravenous use | 1 Vial | SAR 169.70 | NCE · Prescription | Baxter Deutschland GmbH | Valid |
| HOLOXAN 2GM IV. VIAL | 2 g | Powder for injection · Intravenous use | 1 Vial | SAR 324.60 | NCE · Prescription | Baxter Deutschland GmbH | Valid |
| HOLOXAN 500MG VIAL IV | 500 mg | Powder for injection · Intravenous use | 1 Vial | SAR 84.85 | NCE · Prescription | Baxter Deutschland GmbH | Valid |
Indications — CHI Daman Drug Formulary
ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); BURKITT`S LYMPHOMA; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); ENDOMETRIAL CANCER; FOLLICULAR LYMPHOMA; HODGKIN'S LYMPHOMA; OVARIAN CANCER; PEDIATRIC B-CELL LYMPHOMA; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA; T-CELL LYMPHOMA; TESTICULAR CANCER
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| IFEX | 1GM/VIAL; 3GM/VIAL | injectable · injection | BAXTER HLTHCARE | Prescription | 14 Aug 1987 |
| IFOSFAMIDE | 1GM/VIAL; 3GM/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 28 May 2002 |
| IFOSFAMIDE | 1GM/20ML (50MG/ML); 3GM/60ML (50MG/ML) | injectable · injection | MEITHEAL | Prescription | 4 Apr 2007 |
| IFOSFAMIDE | 1GM/20ML (50MG/ML); 3GM/60ML (50MG/ML) | injectable · injection | HIKMA PHARMS | Prescription | 29 Jun 2011 |
| IFOSFAMIDE | 1GM/20ML (50MG/ML); 3GM/60ML (50MG/ML) | injectable · injection | FRESENIUS KABI USA | Discontinued | 22 Sep 2009 |
| IFOSFAMIDE | 1GM/20ML (50MG/ML); 3GM/60ML (50MG/ML) | injectable · injection | EXTROVIS | Discontinued | 26 Nov 2012 |
Canada Canada — marketed products (Health Canada)
WHO WHO Model List of Essential Medicines (2025)
- 8.2.1. Cytotoxic medicines · complementary
Burkitt lymphoma including Burkitt leukaemia; Anaplastic large cell lymphoma, ALK-negative; Anaplastic large cell lymphoma, ALK-positive; Rhabdomyosarcoma primary site; Osteosarcoma of bone or articular cartilage of unspecified sites; Germ cell tumour of testis; Other specified malignant neoplasms of the ovary; Ewing sarcoma of bone or articular cartilage of unspecified sites; Malignant neoplasms of kidney, except renal pelvis
Parenteral > General injections > IV: 500 mg in vial powder for injection; 1 g in vial powder for injection; 2 g in vial powder for injection
Safety signals and safety-related labeling changes
- US FDA 2 Dec 2024 IFEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 13 Feb 2020 PRAC signal: Increased risk of encephalopathy
Action for MAH: update of the product information: No - EMA PRAC 28 Nov 2019 PRAC signal: Increased risk of encephalopathy
Action for MAH: update of the product information: No
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.