Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed.
| Pharmaceutical Form |
|---|
|
Inhalation powder, pre-dispensed (inhalation powder). White powder in a light grey inhaler (ELLIPTA) with a red mouthpiece cover and a dose counter. |
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 65 micrograms umeclidinium bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
Excipient with known effect: Each delivered dose contains approximately 25 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Umeclidinium |
Umeclidinium is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic). It is a quinuclidine derivative that is a muscarinic receptor antagonist with activity across multiple muscarinic cholinergic receptor subtypes. Umeclidinium bromide exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic cholinergic receptors on airway smooth muscle. |
|
| 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 Umeclidinium bromide |
Umeclidinium/vilanterol is a combination inhaled long-acting muscarinic receptor antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA). Following oral inhalation both compounds act locally on airways to produce bronchodilation by separate mechanisms. |
| List of Excipients |
|---|
|
Lactose monohydrate |
The ELLIPTA inhaler consists of a light grey body, red 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 blisters of 7 or 30 doses.
Pack sizes of 7 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/1/14/898/001
EU/1/14/898/002
EU/1/14/898/003
Date of first authorisation: 08 May 2014
Date of latest renewal: 15 January 2019
| Drug | Countries | |
|---|---|---|
| ANORO ELLIPTA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States |
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