Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed
| Pharmaceutical Form |
|---|
|
Inhalation powder, pre-dispensed. White powder in a light grey inhaler (Ellipta) 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 predispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Excipient 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. |
|
| Vilanterol and Fluticasone furoate |
Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. Vilanterol trifenatate is a selective long-acting, beta2-adrenergic agonist (LABA). Molecular interactions occur between corticosteroids and LABAs, whereby steroids activate the beta2-receptor gene, increasing receptor number and sensitivity and LABAs prime the glucocorticoid receptor for steroid-dependent activation and enhance cell nuclear translocation. |
| List of Excipients |
|---|
|
Lactose monohydrate |
The Ellipta 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 blister strips that deliver a total of 14 or 30 doses (14 or 30 day supply).
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/1/13/886/001
EU/1/13/886/002
EU/1/13/886/003
Date of first authorisation: 13 November 2013
Date of latest renewal: 26 July 2018
| Drug | Countries | |
|---|---|---|
| RELVAR | Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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