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.
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 to editors
-
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/
