Salbutamol inhalation products - supply shortage
Ongoing
salbutamol
Shortage
Human
Salbutamol inhalation products are used to treat breathing problems in people with asthma, chronic obstructive pulmonary (lung) disease (COPD) and similar conditions. They contain the active substance salbutamol, which works by relaxing the muscles of the airways in the lungs, making breathing easier.
Salbutamol inhalation products are taken using an inhaler (which releases the medicine in puffs) or a nebuliser (which sprays a fine mist of the medicine).
There has been an increase in demand for salbutamol inhalation products, which cannot be met by the current manufacturing capacity, combined with other manufacturing issues for some of the products.
These issues have led to shortages of some salbutamol inhalation products in most EU/EEA countries.
The shortages are not related to a quality defect or a safety issue with the products.
The shortages may affect the following Member States: Austria, Belgium Bulgaria, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Italy, Latvia, Netherlands, Poland, Slovakia, Slovenia, Spain and Sweden.
The shortage situation depends on the medicine and the Member State concerned. In some countries the shortages may be intermittent. The supply issues are expected to continue at least until mid-2025.
For up-to-date information about the status of a medicine shortage in a particular EU/EEA countries, consult the national shortage register or contact the national competent authority.
EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC) is closely monitoring the supply situation and engaging with several marketing authorisation holders for salbutamol inhalation products to identify measures to mitigate the impact of the supply shortage. In particular, EMA is in close dialogue with companies to investigate whether production can be increased to meet demand.
The SPOC working party is responsible for monitoring and reporting events that could affect the supply of medicines in the EU/EEA.