Bronchitol - supply shortage
Ongoing
mannitol
Shortage
Human
Shortage information
There is an ongoing shortage of Bronchitol in some EU/EEA (European Union/European Economic Area) Member States.
In addition, the company Pharmaxis Europe Limited will stop marketing Bronchitol, 40 mg inhalation powder, hard capsules initiation dose assessment packs and 14‑day packs in selected EU/EEA Member States from October 2025 onwards.
Bronchitol is a medicine used for the treatment of cystic fibrosis in adults, in addition to best standard of care.
In October 2024, the company for Bronchitol, Pharmaxis Europe Limited, had planned to change its distributor. However, this has taken longer than anticipated in some Member States and leading to shortages. It is currently not known how long these shortages will last. In other Member States, the change of distributor was not successful, and for commercial reasons Pharmaxis has decided to discontinue Bronchitol from October 2025 onwards.
The shortage is not related to a quality defect of the product or a safety issue.
The discontinuation of Bronchitol and supply disruption is affecting the following Member States:Austria, Czech Republic, Denmark, Germany, Greece, Hungary, Ireland, Spain and Norway.
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 monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage.
In the countries where Bronchitol remains available, Pharmaxis Europe Limited is prioritising the production of the 14-day packs over the initiation packs to ensure that patients already taking the medicine can continue their treatment.
- In countries where Bronchitol is being discontinued, the medicine will no longer be available for prescribing. Healthcare professionals may consider switching existing patients to an alternative mucolytic treatment, based on available clinical guidance.
- In countries where Bronchitol continues to be marketed (Germany, Ireland, Italy and Spain), shortages are still occurring and no new patients should be started on Bronchitol. Patients may be started on Bronchitol again once supplies of Bronchitol initiation dose assessment packs return to normal. The date of resupply is currently unknown.
- Patients should remain on their standard of care treatment.
- A medicine shortage communication (MSC) has been sent to healthcare professionals in affected Member States and has also be published on EMA website.
- For additional information, consult your country’s shortage register or contact your national competent authority.
- You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations EMA engages with can be found on EMA website.
- If you usually take Bronchitol, contact your pharmacy or doctor well before your current supply runs out.
- If Bronchitol is not available, your healthcare professional will discuss with you whether you need an alternative mucolytic treatment.
- You should continue your standard of care treatment.
- If you have any questions, speak to your doctor or pharmacist.
- For additional information, consult your country’s shortage register or contact your national competent authority.
- You may also contact relevant patients’ organisations for further information or support. A list of European not-for-profit organisations that EMA engages with can be found on the EMA website.
Key facts
- Medicines affected
- Bronchitol
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- mannitol
- Pharmaceutical forms affected
- Inhalation powder
- Strengths affected
- 40 mg
- Availability of alternatives
- Yes
Key dates
- First published