Ifosfamide - supply shortage
Ongoing
ifosfamide
ShortageHuman
Shortage information
There is an ongoing shortage of ifosfamide-containing medicines (marketed by the company Baxter as Holoxan and other names such as Tronoxal and Mitoxana) in the EU/EEA (European Economic Area).
Ifosfamide is a cancer medicine used to treat various cancers, including sarcomas, lymphoma, testicular cancer, lung cancer and ovarian cancer.
A technical problem at the site manufacturing the ifosfamide-containing medicines (marketed by the company Baxter as Holoxan and other names such as Tronoxal and Mitoxana) together with site improvements required after a regulatory inspection in September 2025, led to a short pause in the manufacture and release of ifosfamide. The shortage is not related to a quality defect of the product or a safety issue.
Shortages are expected to continue until Q1 2027, when the manufacturing site is expected to return to full capacity.
The shortage is likely to affect all EU/EEA Member States.
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) are closely monitoring the supply situation and engaging with the marketing authorisation holders, manufacturers, and international regulators to mitigate the impact of the shortages.
The SPOC Working Party supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
- There is an ongoing shortage of ifosfamide (marketed as Holoxan and other names) affecting all EU/EEA Member States that is expected to last until Q1 2027.
- Before starting treatment, healthcare professionals should ensure that sufficient supplies are available to complete a treatment course.
- If ifosfamide is not available, healthcare professionals should consider switching their patients to another medicine, depending on availability of a suitable alternative therapy and in line with relevant clinical guidelines.
- For additional information, consult your country’s shortage register or contact your national competent authority.
- You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations with which EMA engages can be found on the EMA website.
- There is an ongoing shortage of ifosfamide-containing medicines (marketed as Holoxan and other names) affecting all EU/EEA countries that is expected to last until first quarter of 2027.
- Your doctor will check that there are sufficient supplies available before starting treatment with ifosfamide.
- If ifosfamide is not available, your healthcare professional will discuss the treatment options with you.
- You may also contact relevant patients’ organisations for further information or support. A list of European not-for-profit organisations that EMA engages with can be found on the EMA website.
Key facts
- Medicines affected
- Ifosfamide
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- ifosfamide
- Therapeutic area (MESH)
- Cancer
- Pharmaceutical forms affected
- Powder for concentrate for solution for infusion
- Availability of alternatives
- Unknown
Key dates
- Start of supply shortage
- Expected resolution
- Shortages are expected to continue until Q1 2027, when the manufacturing site is expected to return to full capacity.
- First published