Fluorouracil - supply shortage
Ongoing
fluorouracil
ShortageHuman
Shortage information
Fluorouracil given by injection or infusion is used to treat various cancers.
The company Accord, one of the main providers of fluorouracil in the EU, is experiencing capacity issues at one of its manufacturing sites in India. While these issues are being resolved, the company cannot produce sufficient fluorouracil to meet the demand. This has resulted in a shortage which is expected to last until 2025. There are no safety or quality concerns with product on the market.
The shortage affects or may affect all Member States where the product is marketed. For up-to-date information about the status of a medicine shortage in a particular EU/EEA Member State, consult the national shortage register or contact the national competent authority.
EMA’s SPOC working party is closely monitoring the supply situation and engaging with the marketing authorisation holders of alternative fluorouracil medicines to increase their supplies. It is also engaging with Accord to provide regulatory support.
The SPOC working party is responsible for monitoring and reporting events that could affect the supply of medicines in the EU.
- Manufacturing capacity issues are affecting the supply of fluorouracil medicines in some European countries.
- Before starting treatment, healthcare professionals should ensure that sufficient supplies are available to complete the treatment.
- In case of supply shortages, healthcare professionals should consider alternative treatment options for their patients. For additional information consult your country’s shortage register or contact your national competent authority.
- Healthcare professionals may also contact relevant healthcare professional organisations for further information:
- Manufacturing capacity issues are affecting the supply of fluorouracil medicines in some European countries.
- Your doctor will check that there are sufficient supplies available before starting treatment.
- In case fluorouracil medicines become unavailable, your doctor will discuss possible alternatives with you.
- If you have any questions, speak to your doctor or pharmacist.
- For additional information, consult your country’s shortage register or contact your national competent authority
- You may also contact relevant patients’ organisations for further information or support:
- European not-for-profit organisations EMA engages with
Key facts
- Medicines affected
- Fluorouracil
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- fluorouracil
- Therapeutic area (MESH)
- Cancer
- Neoplasms
- Pharmaceutical forms affected
- Solution for injection/infusion
Key dates
- Expected resolution
- 2025
- First published