AIFA wishes to provide information relating to the availability of Fluorouracil-based medicines on the Italian market.

Due to production problems/high demand, Fluorouracil-based medicines are currently in short supply and/or available in reduced quantities.

From the information collected by AIFA, the available packages will not be able to satisfy market demands for the next few months. However, the Agency is in constant contact with the holders of the Marketing Authorisations (AIC) of Fluorouracil-based medicines to obtain updates on any upcoming additional supplies.

Considering that, as reported by the Marketing Authorisation Holders, part of the available packages is bound by obligations of tenders already awarded, the Regions and Autonomous Provinces, together with the relevant health structures, are invited to verify the existence of any existing tenders and the stocks of the medicine and to ascertain from the successful tenderer the effective supply capacity of the medicine in the coming months.

Having said this, as represented by the Italian Association of Medical Oncology (AIOM) "fluorouracil is a drug that is part of numerous treatment schemes for neoplasms of the gastrointestinal system, breast and head and neck area. Its deficiency, albeit transient, represents a real problem for clinical oncology practice also due to the impossibility of replacing it with other drugs for parenteral use. To help overcome the shortage, AIOM invites clinicians to consider alternative therapeutic schemes with oral drugs (capecitabine) for patients who will start a new treatment in the coming weeks, if foreseen in the available guidelines and clinically indicated".

It should be noted, however, that AIFA issues import authorisations for similar products authorised abroad to healthcare facilities that request them.

The form for applications for importation from abroad of medicines currently in short supply on the national territory - pursuant to the Ministerial Decree of 11 May 2001 – is available in the "related links" box.

Finally, for any updates on the state of shortage of these medicines, please refer to the List of shortage medicines, updated periodically and published on the institutional portal in the "Shortage medicines" section.

Published on: 02 May 2024