Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension.
| Pharmaceutical Form |
|---|
|
Pressurised inhalation, suspension (pressurised inhalation). White suspension. |
Each single actuation (delivered dose, the dose leaving the mouthpiece) contains glycopyrronium bromide 9 micrograms equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
This corresponds to a metered dose (i.e. the dose leaving the valve) of glycopyrronium bromide 10.4 micrograms equivalent to 8.3 micrograms of glycopyrronium, and 5.8 microgram of formoterol fumarate dihydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Eformoterol |
Formoterol is a predominantly selective β2-stimulator. Formoterol has bronchodilator activity in patients with reversible obstructive airway diseases. In humans formoterol is effective in the prophylaxis of bronchospasm induced by methacholine challenge. |
|
| Formoterol and Glycopyrronium bromide |
Combination of two bronchodilators: glycopyrronium, a long-acting muscarinic antagonist (also referred to as an anticholinergic), and formoterol, a long-acting β2-adrenergic agonist with a rapid onset of action. |
|
| Glycopyrronium |
Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. |
| List of Excipients |
|---|
|
Norflurane |
The inhaler is a pressurised metered dose inhaler, comprising an aluminium pressurised container with an attached dose indicator, supplied with a white plastic actuator body and mouthpiece with an orange dust cap. Each inhaler is individually packaged in a foil laminate pouch containing a desiccant sachet and packed into a carton.
Pack sizes:
Pack of 1 inhaler with 120 actuations.
Multipack containing 360 (3 inhalers of 120) actuations.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/18/1339/001
EU/1/18/1339/002
Date of first authorisation: 18 December 2018
| Drug | Countries | |
|---|---|---|
| BEVESPI AEROSPHERE | Austria, Estonia, Finland, Croatia, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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