The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 July\u00a02026) approved new\u00a0versions\u00a0of\u00a0Clenil\u00a0Modulite\u00a0100 micrograms inhaler and\u00a0Clenil\u00a0Modulite\u00a0200 micrograms inhaler,\u00a0containing\u00a0beclometasone\u00a0dipropionate for the maintenance treatment of asthma\u00a0in adults and children.\u00a0<\/p>\n
The approval marks the world\u2019s first authorisation of pressurised metered-dose inhalers\u00a0(pMDI) using the next-generation propellant HFA-152a.\u00a0The propellant itself is not an active medicine but is used to deliver the inhaled dose.\u00a0\u00a0<\/p>\n
These\u00a0new versions\u00a0will be available in the UK\u00a0later in\u00a02026. In the meantime, the current versions\u00a0of\u00a0Clenil\u00a0Modulite\u00a0will continue to be available to patients.\u00a0<\/p>\n
Asthma is a common long-term condition affecting the airways in the lungs.\u00a0Symptoms can include wheezing, coughing, chest\u00a0tightness,\u00a0and shortness of breath.\u00a0<\/p>\n
Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said:\u00a0<\/p>\n
\u201cKeeping patients safe and enabling their access to high-quality, safe and effective medicines are key priorities for us.\u00a0<\/p>\n
\u201cAsthma inhalers play a vital role in helping millions of patients manage their condition and maintain their quality of life.\u00a0<\/p>\n
\u201cThis approval marks the world\u2019s first authorisation of an inhaler using the next-generation propellant HFA-152a. It\u00a0demonstrates\u00a0how innovation can support both patient care and environmental sustainability while\u00a0maintaining\u00a0the\u00a0high standards\u00a0of quality, safety and effectiveness patients expect.\u00a0<\/p>\n
\u201cAs with all medicines, we will continue to monitor its safety and effectiveness closely.\u201d\u00a0<\/p>\n
The medicine\u00a0is administered\u00a0via a\u00a0pressurised metered-dose inhaler\u00a0and\u00a0is used regularly to help prevent asthma symptoms.\u00a0<\/p>\n
The active ingredient,\u00a0beclometasone\u00a0dipropionate, is a corticosteroid that reduces inflammation in the airways, helping to prevent asthma symptoms and exacerbations.\u00a0<\/p>\n
No changes have been made to the active ingredient, recommended doses or therapeutic indications. The MHRA\u2019s 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.<\/p>\n
The most common side effects of\u00a0beclometasone\u00a0inhalers include oral thrush, hoarseness of the voice,\u00a0and throat irritation.\u00a0A 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\u00a0the\u00a0\u00a0of\u00a0the medicine becomes\u00a0available.\u00a0<\/p>\n
As with any medicine, the MHRA will keep the safety and effectiveness of beclometasone\u00a0dipropionate\u00a0under close review.<\/p>\n
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\u00a0https:\/\/yellowcard.mhra.gov.uk<\/a>\u00a0or via the MHRA Yellow Card app.\u00a0<\/p>\n Notes to editors\u202f\u202f\u00a0<\/p>\n The\u00a0variation\u00a0to the\u00a0existing\u00a0marketing authorisation was granted on\u00a021\u00a0July\u00a02026\u00a0to Chiesi Limited.\u00a0<\/p>\n An updated\u00a0Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL),\u00a0will be published on the MHRA Products website\u00a0once the\u00a0new version\u00a0of the\u00a0medicine\u00a0is available.\u00a0\u00a0<\/p>\n