5 August 2024
EMA/333979/2024

Shortage of fluorouracil
Solution for injection or infusion, various strengths
What isFluorouracil given by injection or infusion is used to treat various cancers.

fluorouracil usedfor?
Reason for

The company Accord, one of the main providers of fluorouracil in the EU, isshortage

experiencing capacity issues at one of its manufacturing sites in India. Whilethese issues are being resolved, the company cannot produce sufficient
fluorouracil to meet the demand. This has resulted in a shortage which isexpected to last until 2025. There are no safety or quality concerns withproduct on the market.

Member States

The shortage affects or may affect all Member States where the product isaffectedmarketed.
For up-to-date information about the status of a medicine shortage in aparticular EU/EEA Member State, consult the national shortage register orcontact the national competent authority.

Monitoring ofEMA’s SPOC working party is closely monitoring the supply situation andshortage

engaging with the marketing authorisation holders of alternative fluorouracil
medicines to increase their supplies. It is also engaging with Accord to provideregulatory support.
The SPOC working party is responsible for monitoring and reporting events
that could affect the supply of medicines in the EU. Summaries of the SPOC
working party meetings can be found on EMA’s website.

Information to•

medicines in some European countries.

healthcareprofessionals

Manufacturing capacity issues are affecting the supply of fluorouracil•

Before starting treatment, healthcare professionals should ensure thatsufficient 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 professionalorganisations for further information. A list of European not-for-profit
organisations EMA engages with can be found on the EMA website.

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An agency of the European Union© European Medicines Agency, 2024. Reproduction is authorised provided the source is acknowledged.

Shortage of fluorouracil
Solution for injection or infusion, various strengths
Information to•

medicines in some European countries.

patients andcarers

Manufacturing capacity issues are affecting the supply of fluorouracil•

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 orcontact your national competent authority•

You may also contact relevant patients’ organisations for furtherinformation or support. A list of European not-for-profit organisations that
EMA engages with can be found on the EMA website.

Status

EMA/333979/2024

Ongoing

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