Ifosfamide shortage — AU supply status & alternatives

Ifosfamide

—

🇦🇺 AUST R 43606 · Baxter Healthcare Pty Ltd

In shortage · Australia

HOLOXAN ifosfamide

In declared shortage · 🇦🇺 Australia & also short in🇨🇦 CA🇮🇹 IT🇩🇪 DE🌐 EU🇫🇷 FR🇺🇸 US🇧🇪 BE🇳🇱 NL+1

Critical shortage

Available

Reading today’s signals…

🇦🇺 AUAEMPA$38.24details →

✓ Can I substitute?

Yes — under S19A

TGA s19A · ifosfamide-injection-1g-20ml-50mgml-intravenous-use-single-dose-vial-hikma-usa

Product attributes reference data we hold

Active ingredient (INN)	Ifosfamide
Brand names	HOLOXAN ifosfamide
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	BAXTER HEALTHCARE LIMITED, HIKMA PHARMACEUTICALS USA INC., Baxter Healthcare Pty Ltd, BAXTER HEALTHCARE CORPORATION +2 more
Registrations on file	10
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$38.24

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

ifosfamide 1 g injection, 1 vial

Source: PBSEffective July 2026 · AUD

Substitution pathways 🇦🇺 Australia · TGA

✓

Section 19A approval in force · ifosfamide-injection-1g-20ml-50mgml-intravenous-use-single-dose-vial-hikma-usa

TGA Section 19A: overseas-registered 'Ifosfamide Injection 1g per 20mL (50mg/mL) for intravenous use, single dose vial (Hikma, USA).' approved for import and supply in Australia during a shortage. Expires July 2026. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · ifosfamide-1g-powder-injection-single-dose-vial-baxter-usa

TGA Section 19A: overseas-registered 'Ifosfamide 1g powder for injection single dose vial (Baxter, USA)' approved for import and supply in Australia during a shortage. Origin: Baxter, USA. Expires Jan 2027. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · ifosfamide-3g-powder-injection-single-dose-vial-baxter-usa

TGA Section 19A: overseas-registered 'Ifosfamide 3g powder for injection single dose vial (Baxter, USA)' approved for import and supply in Australia during a shortage. Origin: Baxter, USA. Expires Jan 2027. Verify on TGA Section 19A approvals ↗

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

4 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Moderate concentration risk

Baxter Healthcare CorpJiangsu Hengrui Pharmaceuticals CO LTDIfotam CO LTDAarti Pharmalabs LTD

Manufacturing countries: United States, China, India · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🇨🇦

Canada

HC · 2h ago

Critical

🇦🇺

Australia

TGA · 2h ago

Critical

🇮🇹

Italy

AIFA · 8h ago

Critical

🇧🇪

FAMHP · 3h ago

High

🌐

EMA · 1d ago

High

🇩🇪

Germany

BfArM · 10d ago

High

🇺🇸

United States

FDA · 2h ago

Medium

🇳🇱

Netherlands

CBG-MEB · 7h ago

Medium

Recalls official enforcement reports

🇨🇦

Ifosfamide for Injection

Marketed health products · June 2026

Class ?details ↗

🇦🇺

Ifosfamide 2,900mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous InfusionBatc

Slade Health Pty Ltd · June 2026

Class IIdetails ↗

🇺🇸

Ifosfamide

Infusion Options, Inc. · June 2019

Class IIdetails ↗

🇺🇸

Ifosfamide Injection

AmeriSource Bergen · Sept 2013

Class IIdetails ↗

🇺🇸

Ifosfamide Injection

AmeriSource Bergen · Sept 2013

Class IIdetails ↗

Verified timeline regulator events

🌐 2 Dec 2026

high reported

🇦🇺 1 July 2026

critical reported

🇦🇺 18 June 2026

critical reported

🇺🇸 12 June 2026

medium reported

🇳🇱 12 June 2026

medium reported

🇫🇷 11 June 2026

medium reported

Sources official regulators

🇨🇦

verified 2h ago

verify ↗

🇺🇸

FDA

verified 2h ago

verify ↗

🇦🇺

TGA

verified 2h ago

verify ↗

🇧🇪

FAMHP

verified 3h ago

verify ↗

🇳🇱

CBG-MEB

verified 7h ago

verify ↗

🇮🇹

AIFA

verified 8h ago

verify ↗

🇫🇷

ANSM

verified 10h ago

verify ↗

🌐

EMA

verified 1d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders10 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
IFOSFAMIDE INJECTION 1 G	1 G	injection	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
IFOSFAMIDE INJECTION 2G	2G	injection	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
Ifosfamide	50mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
HOLOXAN ifosfamide	500mg	—	🇦🇺 AU	Baxter Healthcare Pty Ltd	Active
HOLOXAN ifosfamide	1g	—	🇦🇺 AU	Baxter Healthcare Pty Ltd	Active
HOLOXAN ifosfamide	2g	—	🇦🇺 AU	Baxter Healthcare Pty Ltd	Active
IFOSFAMIDE	1g/20mL	injection	🇺🇸 US	BAXTER HEALTHCARE CORPORATION	Active
IFOSFAMIDE	3g/60mL	injection	🇺🇸 US	BAXTER HEALTHCARE CORPORATION	Active
Ifosfamide	1g/1	injection	🇺🇸 US	FRESENIUS KABI USA, LLC	Active
Ifosfamide For	—	solution	🇨🇦 CA	FRESENIUS KABI CANADA LTD	Active

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.