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Overseas-Registered Products Available for Cyclophosphamide and Ifosfamide Injection Shortages

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Summary

Baxter Healthcare has notified TGA Australia that global supply constraints due to manufacturing issues are affecting Endoxan (cyclophosphamide) 2g and Holoxan (ifosfamide) 2g powder for injection vials. These medicines are used to treat various types of cancer, diseases of the immune system, and to prevent rejection of organ transplants. The shortages are expected to continue until the end of June 2026. TGA has approved the supply of multiple overseas-registered cyclophosphamide and ifosfamide injection products under section 19A of the Therapeutic Goods Act 1989 to reduce the impact of these shortages.

Published by TGA on tga.gov.au . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

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What changed

Baxter Healthcare has notified TGA Australia of global supply constraints affecting cyclophosphamide (Endoxan) 2g and ifosfamide (Holoxan) 2g powder for injection vials due to manufacturing issues. The shortages are expected to persist until the end of June 2026. TGA has exercised its powers under section 19A of the Therapeutic Goods Act 1989 to approve the supply of multiple overseas-registered alternative products in various strengths to mitigate the shortage impact.

Healthcare providers treating patients who rely on these chemotherapy agents and immune system treatments should consult the Section 19A approvals database and Medicine shortage reports database to identify approved alternatives and sourcing options. Pharmacies and hospitals should review current stock and sourcing procedures to ensure continuity of care for cancer patients and transplant recipients during this shortage period.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Overseas-registered products available for cyclophosphamide and ifosfamide injection shortages

Published

22 April 2026

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    • Email Baxter Healthcare has notified us that global supply constraints due to manufacturing issues are affecting the following medicines:
  • Endoxan (cyclophosphamide) 2 g (as monohydrate) powder for injection vial

  • Holoxan (ifosfamide) 2 g powder for injection vial.
    These medicines are used to treat various types of cancer. Cyclophosphamide is also used to treat some diseases of the immune system, and to prevent rejection of organ transplants.

The shortages are expected to continue until the end of June 2026.

We have approved the supply of multiple overseas-registered cyclophosphamide and ifosfamide injection products in various strengths under section 19A of the Therapeutic Goods Act 1989 to reduce the impact of these shortages.

Go to About the cyclophosphamide and ifosfamide injection shortages for more information about the shortages, including details of the overseas-registered products and how to obtain them.

The Section 19A approvals database and the Medicine shortage reports database also provide up-to-date information about these products and the shortages (search by the active ingredient).

Topics
- Shortages and supply disruptions
Featured in
- Prescription medicines collection
Product types
- Prescription medicines

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Last updated

Classification

Agency
TGA
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers Pharmaceutical companies Patients
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug shortage management Import approval Supply disruption response
Geographic scope
Australia AU

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Topics
Public Health Healthcare Supply Chain

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