Cyclophosphamide - supply shortage
Ongoing
cyclophosphamide
ShortageHuman
Shortage information
There is an ongoing shortage of intravenous cyclophosphamide-containing medicines (marketed by the company Baxter as Endoxan, Sendoxan and Genoxal) in the EU/EEA (European Economic Area).
Cyclophosphamide is a cancer medicine used to treat various cancers, including sarcoma, lymphoma, lung cancer, ovarian cancer as well as severe autoimmune conditions such as vasculitis (inflammation of blood vessels) and nephritis (kidney inflammation) and in preparation for bone marrow transplantation.
A technical problem at the site manufacturing cyclophosphamide-containing medicines, together with site improvements required after a regulatory inspection in September 2025, led to a short pause in the manufacture and release of cyclophosphamide. Although manufacturing has now resumed at the facility, the pause led to a shortage which is expected to continue until Q1 2027, when the site is expected to return to full capacity.
The shortage is not related to a quality defect of the product or a safety issue.
The shortage is likely to affect all EU/EEA Member States.
EMA is closely monitoring the supply situation of cyclophosphamide and alternative medicines, and is engaging with Baxter, alternative manufacturer and international regulators to mitigate the impact of the shortage.
Monitoring is carried out by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party). For further information see ‘related information’.
- There is an ongoing shortage of intravenous cyclophosphamide-containing medicines (marketed by the company Baxter as Endoxan, Sendoxan and Genoxal) affecting all EU/EEA Member States, which is expected to last until Q1 2027.
- Intravenous cyclophosphamide-containing medicines marketed by other companies may be available; healthcare professionals should check if they can obtain intravenous cyclophosphamide from another supplier.
- Before starting treatment, healthcare professionals should ensure that sufficient supplies are available to complete a treatment course.
- If no intravenous cyclophosphamide-containing medicine is 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 intravenous (given into a vein) cyclophosphamide-containing medicines affecting all EU/EEA countries that is expected to last until first quarter of 2027.
- Your doctor will check that you can finish your treatment course before prescribing intravenous cyclophosphamide.
- If intravenous cyclophosphamide 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
- Cyclophosphamide
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- cyclophosphamide
- Therapeutic area (MESH)
- Cancer
- Pharmaceutical forms affected
- Powder for solution for injection or infusion
- Availability of alternatives
- Unknown
Key dates
- Start of supply shortage
- Expected resolution
- Expected to continue until Q1 2027.
- First published