MHRA approves world's first lower-carbon beclometasone inhalers for patients with asthma
The new inhalers use a next-generation propellant designed to reduce environmental impact while maintaining the same established treatment.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 July听2026) approved new听versions听of听Clenil听Modulite听100 micrograms inhaler and听Clenil听Modulite听200 micrograms inhaler,听containing听beclometasone听dipropionate for the maintenance treatment of asthma听in adults and children.听
The approval marks the world鈥檚 first authorisation of pressurised metered-dose inhalers听(pMDI) using the next-generation propellant HFA-152a.听The propellant itself is not an active medicine but is used to deliver the inhaled dose.听听
These听new versions听will be available in the UK听later in听2026. In the meantime, the current versions听of听Clenil听Modulite听will continue to be available to patients.听
Asthma is a common long-term condition affecting the airways in the lungs.听Symptoms can include wheezing, coughing, chest听tightness,听and shortness of breath.听
Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said:听
鈥淜eeping patients safe and enabling their access to high-quality, safe and effective medicines are key priorities for us.听
鈥淎sthma inhalers play a vital role in helping millions of patients manage their condition and maintain their quality of life.听
鈥淭his approval marks the world鈥檚 first authorisation of an inhaler using the next-generation propellant HFA-152a. It听demonstrates听how innovation can support both patient care and environmental sustainability while听maintaining听the听high standards听of quality, safety and effectiveness patients expect.听
鈥淎s with all medicines, we will continue to monitor its safety and effectiveness closely.鈥澨�
The medicine听is administered听via a听pressurised metered-dose inhaler听and听is used regularly to help prevent asthma symptoms.听
The active ingredient,听beclometasone听dipropionate, is a corticosteroid that reduces inflammation in the airways, helping to prevent asthma symptoms and exacerbations.听
No changes have been made to the active ingredient, recommended doses or therapeutic indications. The MHRA鈥檚 approval is supported by evidence which demonstrates that the new formulations perform comparably to the currently authorised products while maintaining the same quality, safety, and clinical benefit.
The most common side effects of听beclometasone听inhalers include oral thrush, hoarseness of the voice,听and throat irritation.听A full list of side effects for the current version of the product can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be updated when听the听听of听the medicine becomes听available.听
As with any medicine, the MHRA will keep the safety and effectiveness of beclometasone听dipropionate听under close review.
Anyone who suspects they are experiencing a side effect should speak to their doctor, pharmacist or nurse and report it directly through the Yellow Card scheme at听听or via the MHRA Yellow Card app.听
Notes to editors鈥��
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The听variation听to the听existing听marketing authorisation was granted on听21听July听2026听to Chiesi Limited.听
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An updated听Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL),听will be published on the MHRA Products website听once the听new version听of the听medicine听is available.听听
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For more information about asthma, visit:听听
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The Medicines and Healthcare products Regulatory Agency (MHRA)听is responsible for听regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.鈥� All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.鈥��
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The MHRA is an executive agency of the Department of Health and Social Care.鈥��
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For media enquiries, please contact the听newscentre@mhra.gov.uk, or call on 020 3080 7651.