BECOTIDE EVOHALER Pressurised inhalation, solution Ref.[49849] Active ingredients: Beclometasone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Becotide Evohaler 50 micrograms, Pressurised Inhalation Solution.

Pharmaceutical Form

Pressurised Inhalation, Solution.

Clear and colourless solution in an aluminium canister with a valve.

Qualitative and quantitative composition

One metered dose contains 50 micrograms of Beclometasone Dipropionate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Beclometasone

Beclometasone is a pro-drug with weak glucocorticoid receptor binding affinity. It is extensively hydrolysed via esterase enzymes to the active metabolite beclometasone-17-monopropionate (B-17-MP), which has potent topical anti-inflammatory activity.

List of Excipients

Norflurane (Hydrofluoroalkane (HFA) 134a)
Ethanol anhydrous
Glycerol

Pack sizes and marketing

The inhaler comprises an aluminium can fitted with a 50 microlitre metering valve, plastic actuator and dust cap. Each canister contains 200 metered doses.

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA1077/042/006

Date of first authorisation: 07 January 2005
Date of last renewal: 07 January 2010

Drugs

Drug Countries
BECOTIDE Spain, France, Ireland, Italy, South Africa

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