Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
AVAMYS 27.5 micrograms/spray, nasal spray suspension.
Pharmaceutical Form |
---|
Nasal spray, suspension. White suspension. |
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 |
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Glucose anhydrous |
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.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
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
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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