ATIMOS MODULITE Pressurised inhalation solution Ref.[6862] Active ingredients: Eformoterol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom

Product name and form

Atimos Modulite 12 micrograms/actuation pressurised inhalation solution.

Pharmaceutical Form

Pressurised inhalation solution.

Qualitative and quantitative composition

Each metered dose contains 12 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose of 10.1 micrograms.

For a full list of excipients, see section 6.1.

Excipient with known effect: This medicine contains 8,9 mg of alcohol (ethanol) in each actuation, which is equivalent to 0,25 mg/kg per dose of two actuations in adults and equivalent to 0,44 mg/kg per dose of two actuations in adolescent for Ethanol.

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.

List of Excipients

Norflurane
Ethanol anhydrous
Hydrochloric acid

Pack sizes and marketing

1 pressurised, aluminium container fitted with a metering valve, actuator and protective cap, containing a pressurised inhalation solution.

Each canister provides 50, 100 or 120 actuations.

Not all pack size may be marketed.

Marketing authorization holder

Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom

Marketing authorization dates and numbers

PL 08829/0154

20/05/2011

Drugs

Drug Countries
ATIMOS Germany, Estonia, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, United Kingdom

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