RELVAR ELLIPTA Inhalation powder, pre-dispensed Ref.[50872] Active ingredients: Fluticasone furoate Vilanterol Vilanterol and Fluticasone furoate

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

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.

Qualitative and quantitative composition

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
Magnesium stearate

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

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

Drugs

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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