Perfusion solutions - supply shortage
Ongoing
Shortage
Human
There is a shortage of perfusion solutions in the EU/EAA (European Economic Area). Perfusion solutions are given by intravenous infusion (by a drip into a vein) to replace fluids or to carry another medicine into the body. They are also used as irrigation fluids (to rinse or bathe an organ or tissue during or after surgery or when caring for a wound).
Some of the companies that produce perfusion solutions are experiencing some short-term manufacturing problems, together with an unexpected increase in demand for these solutions, which cannot be met by the current manufacturing capacity. In addition, an important manufacturing site in the USA recently suffered hurricane damage, which has also affected supplies in the EU. Together with commercially driven reductions in output, these events have led to a shortage of perfusion solutions. The shortage is not related to a quality defect of the products or a safety issue.
For specific solutions (irrigation fluids), low quantities remain available in certain countries. The shortage is expected to last until the end of 2025.
The shortage affects the following Member States where the products are marketed: Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Italy, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
This information may change. 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 to monitor the supply situation and engage with the marketing authorisation holders and other stakeholders to mitigate the impact of the supply shortage.
In addition, the marketing authorisation holders are working to increase production capacity. They are also reallocating available stocks and sourcing products from manufacturing sites in countries outside the EU/EEA.