FLIXOTIDE EVOHALER Pressurised inhalation, suspension Ref.[6859] Active ingredients: Fluticasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Product name and form

Flixotide 50 micrograms Evohaler.

Flixotide 125 micrograms Evohaler.

Flixotide 250 micrograms Evohaler.

Pharmaceutical Form

Pressurised inhalation, suspension.

Flixotide Evohaler does not contain any chlorofluorocarbons (CFCs).

Qualitative and quantitative composition

Flixotide 50 micrograms Evohaler, Flixotide 125 micrograms Evohaler and Flixotide 250 micrograms Evohaler are pressurised inhalation, suspensions, delivering either 50, 125 or 250 micrograms of fluticasone propionate per actuation, respectively.

Active Ingredient Description
Fluticasone

Fluticasone has anti-inflammatory and vasoconstrictive features. Fluticasone given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.

List of Excipients

HFA 134a

Pack sizes and marketing

An inhaler comprising an aluminium alloy can sealed with a metering valve, actuator and dust cap. Each canister contains 120 metered actuations of either 50, 125 or 250 micrograms of fluticasone propionate. (60 metered actuation hospital packs are available in the 125 or 250 microgram products).

Marketing authorization holder

Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Marketing authorization dates and numbers

Flixotide 50 micrograms Evohaler: PL 10949/0324
Flixotide 125 micrograms Evohaler: PL 10949/0265
Flixotide 250 micrograms Evohaler: PL 10949/0266

Flixotide Evohaler 50 micrograms: 27 June 2000
Flixotide Evohaler 125/250 micrograms: 14 March 2000

Drugs

Drug Countries
FLIXOTIDE Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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