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SMC ID Date Medicine Submission Type Indication
SMC2652 08/04/2024 glycopyrronium/formoterol fumarate (Bevespi Aerosphere) Abbreviated

Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
SMC2334 08/08/2022 beclometasone dipropionate/formoterol fumarate dehydrate/glycopyrronium bromide (Trimbow) Abbreviated

Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
SMC2355 10/05/2021 indacaterol/glycopyrronium/mometasone furoate (Enerzair Breezhaler) Abbreviated

As a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.
SMC2377 10/05/2021 glycopyrronium/formoterol fumarate dihydrate (Bevespi Aerosphere) Non submission

Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease.
SMC2335 08/03/2021 beclometasone dipropionate/formoterol fumarate dehydrate/glycopyrronium bromide (Trimbow) Abbreviated

Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
SMC2321 08/02/2021 formoterol fumarate dihydrate/glycopyrronium/budesonide (Trixeo Aerosphere) Abbreviated

Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long‑acting beta2‑agonist or combination of a long-acting beta2‑agonist and a long‑acting muscarinic antagonist.
1274/17 09/10/2017 beclometasone dipropionate anhydrous/formoterol fumarate dihydrate/glycopyrronium bromide (Trimbow) Abbreviated

Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.
1254/17 10/07/2017 glycopyrronium bromide (Sialanar) Abbreviated For symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
922/13 08/12/2014 indacaterol maleate, glycopyrronium bromide (Ultibro Breezhaler) Abbreviated maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
829/12 14/01/2013 glycopyrronium (Seebri Breezhaler) Full For a once daily maintenance bronchodilator treatment to relieve symptoms in patients with COPD.

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