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HSA Approval

ANORO ELLIPTA INHALATION POWDER 62.5 MCG/25 MCG

SIN14838P

ANORO ELLIPTA INHALATION POWDER 62.5 MCG/25 MCG

ANORO ELLIPTA INHALATION POWDER 62.5 MCG/25 MCG

August 28, 2015

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

Formulation Information

POWDER, METERED

**Dosage and Administration** Pharmaceutical form: Inhalation powder, pre-dispensed _ANORO ELLIPTA_ is for oral inhalation only. _ANORO ELLIPTA_ should be administered once daily at the same time each day. **Adults** The recommended and maximum dose is one inhalation of _ANORO ELLIPTA_ 62.5/25 micrograms once daily. **Children** Use in patients less than 18 years of age is not relevant given the indication for this product. **Elderly** No dosage adjustment is required in patients over 65 years (see _Pharmacokinetics – Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Renal impairment** No dosage adjustment is required in patients with renal impairment (see _Pharmacokinetics — Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Hepatic impairment** No dosage adjustment is required in patients with mild or moderate hepatic impairment. _ANORO ELLIPTA_ has not been studied in patients with severe hepatic impairment (see _Pharmacokinetics — Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

RESPIRATORY (INHALATION)

Medical Information

**Indications** _ANORO ELLIPTA_ is indicated for maintenance bronchodilator treatment to relieve symptoms associated with chronic obstructive pulmonary disease (COPD).

**Contraindications** _ANORO ELLIPTA_ is contraindicated in patients with severe milk-protein allergy, or who have demonstrated hypersensitivity to either umeclidinium, vilanterol or any of the excipients in this product.

R03AL03

vilanterol and umeclidinium bromide

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)

GLAXOSMITHKLINE LLC

Active Ingredients

(VI STRIP) VILANTEROL TRIFENATATE (MICRONISED) 40 mcg/dose EQV VILANTEROL

25 mcg/dose

Vilanterol

(UMEC STRIP) UMECLIDINIUM BROMIDE (MICRONISED) 74.2 mcg/dose EQV UMECLIDINIUM

62.5 mcg/dose

Umeclidinium bromide

Documents

Package Inserts

ANORO ELLIPTA INHALATION POWDER PI.pdf

Approved: February 24, 2023

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