Fludarabine - supply shortage
Ongoing
fludarabine
ShortageHuman
Shortage information
There is a shortage of medicines containing fludarabine in the European Union (EU).
Medicines containing fludarabine are used to treat adults with chronic lymphocytic leukaemia.
A general shortage of the active pharmaceutical ingredient and an unexpected increase in demand for fludarabine medicines have led to a supply issue for several manufacturers across Europe. This has resulted in shortages of medicines containing fludarabine. The shortage is not related to a quality defect of the product or a safety issue.
The shortage is expected to last until December 2025.
The shortage affects several EU Member States where the product is marketed.
For up-to-date information about the status of a medicine shortage in a particular Member State, consult the national shortage register or contact the national competent authority.
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 holder to mitigate the impact of the supply shortage.
The SPOC Working Party Supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
- Before starting treatment, healthcare professionals should ensure that sufficient supplies are available and check with their national competent authority whether new patients can be started on fludarabine;
- In case fludarabine is not available, healthcare professionals should consider alternative treatments for patients already receiving fludarabine, taking in consideration local and national guidance;
- For additional information consult your country’s shortage register or contact your national competent authority.
- Before starting treatment, your doctor will make sure that sufficient supplies are available;
- If medicines containing fludarabine are not available, your doctor will discuss possible alternatives with you;
- If you have any questions, speak to your doctor;
- For additional information, please consult your country’s shortage register or contact your national competent authority.
Key facts
- Medicines affected
- Fludarabine
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- fludarabine
- Therapeutic area (MESH)
- Leukemia
- Pharmaceutical forms affected
- Concentrate for solution for injection/infusion
- Strengths affected
- 25 mg/ml
- Availability of alternatives
- Unknown
Key dates
- Expected resolution
- The shortage is expected to last until December 2025.
- First published
- Last updated