Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed.
| Pharmaceutical Form |
|---|
|
Inhalation powder, pre-dispensed (Inhalation powder). White powder in a light grey inhaler with a yellow mouthpiece cover and a dose counter. |
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Excipients with known effect: Each delivered dose contains approximately 25 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
|
| Vilanterol |
Vilanterol is a selective long-acting, beta2-adrenergic agonist (LABA). The pharmacologic effects of beta2-adrenoceptor agonist active substances, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. |
| List of Excipients |
|---|
|
Lactose monohydrate |
The inhaler consists of a light grey body, a yellow mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet. The tray is sealed with a peelable foil lid.
The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
The inhaler contains two aluminium foil laminate strips of 14 or 30 doses.
Pack sizes of 14 or 30 dose Inhalers. Multipack of 3 × 30 dose Inhalers.
Not all pack sizes may be marketed.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
EU/1/14/929/001
EU/1/14/929/002
EU/1/14/929/003
Date of first authorisation: 02 May 2014
Date of latest renewal: 26 July 2018
| Drug | Countries | |
|---|---|---|
| REVINTY ELLIPTA | Austria, Germany, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, South Africa |
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