MHRA approves world’s first lower-carbon…

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 July 2026) approved new versions of Clenil Modulite 100 micrograms inhaler and Clenil Modulite 200 micrograms inhaler, containing beclometasone dipropionate for the maintenance treatment of asthma in adults and children.

The approval marks the world’s first authorisation of pressurised metered-dose inhalers (pMDI) using the next-generation propellant HFA-152a. The propellant itself is not an active medicine but is used to deliver the inhaled dose.

These new versions will be available in the UK later in 2026. In the meantime, the current versions of Clenil Modulite will continue to be available to patients.

Asthma is a common long-term condition affecting the airways in the lungs. Symptoms can include wheezing, coughing, chest tightness, and shortness of breath.

Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said:

“Keeping patients safe and enabling their access to high-quality, safe and effective medicines are key priorities for us.

“Asthma inhalers play a vital role in helping millions of patients manage their condition and maintain their quality of life.

“This approval marks the world’s first authorisation of an inhaler using the next-generation propellant HFA-152a. It demonstrates how innovation can support both patient care and environmental sustainability while maintaining the high standards of quality, safety and effectiveness patients expect.

“As with all medicines, we will continue to monitor its safety and effectiveness closely.”

The medicine is administered via a pressurised metered-dose inhaler and is used regularly to help prevent asthma symptoms.

The active ingredient, beclometasone dipropionate, is a corticosteroid that reduces inflammation in the airways, helping to prevent asthma symptoms and exacerbations.

No changes have been made to the active ingredient, recommended doses or therapeutic indications. The MHRA’s 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 beclometasone inhalers include oral thrush, hoarseness of the voice, and throat irritation. 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 the  of the medicine becomes available.

As with any medicine, the MHRA will keep the safety and effectiveness of beclometasone dipropionate 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 https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app.

Notes

• The variation to the existing marketing authorisation was granted on 21 July 2026 to Chiesi Limited.
• An updated Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), will be published on the MHRA Products website once the new version of the medicine is available.
• For more information about asthma, visit: https://www.nhs.uk/conditions/asthma/
• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
• The MHRA is an executive agency of the Department of Health and Social Care.

source: GOV