Riltrava Aerosphere (formoterol fumarate dihydrate/glycopyrronium/budesonide) / AstraZeneca - LARVOL DELTA

On 23 July 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Riltrava Aerosphere. (European Medicines Agency) - "The CHMP adopted a new strength of the pressurised inhalation suspension (5 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 18 micrograms, equivalent to 14.4 micrograms of glycopyrronium, and budesonide 160 micrograms) associated with a new indication as follows: Riltrava Aerosphere is indicated as a maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid and a long-acting beta2-agonist."

CHMP • Asthma • Immunology

CHMP recommends 11 new medicines for authorization, including two COVID-19 monoclonal antibodies (Regulatory Affairs Professionals Society) - "AstraZeneca was granted a positive opinion for its informed consent application for Riltrava Aerosphere (formoterol fumarate dihydrate/glycopyrronium/budesonide) for treating chronic obstructive pulmonary disease in adults whose disease is not adequately controlled by other medications."

European regulatory • Chronic Obstructive Pulmonary Disease • Respiratory Diseases