AVAMYS Nasal spray, suspension Ref.[6858] Active ingredients: Fluticasone Fluticasone furoate

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

AVAMYS 27.5 micrograms/spray, nasal spray suspension.

Pharmaceutical Form

Nasal spray, suspension.

White suspension.

Qualitative and quantitative composition

Each spray actuation delivers 27.5 micrograms of fluticasone furoate.

Excipient with known effect: One actuation delivers 8.25 micrograms of benzalkonium chloride.

For the full list of excipients, see section 6.1.

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.

Fluticasone furoate

Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very high affinity for the glucocorticoid receptor and has a potent anti-inflammatory action.

List of Excipients

Glucose anhydrous
Dispersible cellulose
Polysorbate 80
Benzalkonium chloride
Disodium edetate
Purified water

Pack sizes and marketing

14.2 ml Type I or Type III amber bottle (glass) fitted with a metering spray pump.

The medicinal product is available in three pack sizes: 1 bottle of 30, 60 or 120 sprays.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/07/434/001
EU/1/07/434/002
EU/1/07/434/003

Date of first authorisation: 11 January 2008
Date of latest renewal: 17 December 2012

Drugs

Drug Countries
AVAMYS Austria, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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