Brevibloc

The company for Brevibloc is experiencing manufacturing issues due to the discontinuation of manufacturing activities by the supplier of the active substance esmolol. This has led to a shortage of Brevibloc. The shortage is not related to a quality defect of the product or a safety issue.

The shortage is expected to last until the end of 2027.

The shortage affects some of the countries where the product is marketed: 

• Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden (Brevibloc vials)
• Denmark, Finland, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden (Brevibloc bags)

This information may change. For up-to-date information about the status of a medicine shortage in a particular country, consult the national shortage register or contact the national competent authority using the below links.

EMA is closely monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage. 

In addition, to help manage the shortage, the company that markets Brevibloc is supplying an equivalent esmolol medicine from outside the EU to some affected countries and is working with authorities to make it available in all affected EU countries.

The company has also found a new supplier of the active substance esmolol and is taking the necessary steps to obtain approval to use this supplier in the EU. National medicines authorities are supporting this process.

Monitoring of the shortage is carried out by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party). For further information see ‘related information’.

• There is an ongoing shortage of Brevibloc in EU/EEA countries, which is expected to last until the end of 2027.
• An equivalent esmolol-containing product authorised outside the EU may be available in some EU countries.
• Healthcare professionals should consider prescribing other esmolol-containing medicines marketed by other companies, depending on availability.
• For additional information consult your country’s shortage register, where available, or contact your national competent authority.

• There is a shortage of Brevibloc (esmolol) in some EU/EEA countries, which is expected to last until the end of 2027. Brevibloc is given in hospitals to quickly lower and control a fast heart rate or high blood pressure, including during or after surgery
• If Brevibloc is not available, your healthcare team will decide on the most appropriate treatment for you.
• If you have any questions, speak to your doctor or pharmacist. 
• For additional information, consult your country’s shortage register, where available, or contact your national competent authority using the below links.