United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - vilanterol trifenatate; umeclidinium bromide - inhalation powder - 22microgram/1dose ; 65microgram/1dose

United States - English - NLM (National Library of Medicine)

glaxosmithkline llc - umeclidinium bromide (unii: 7an603v4jv) (umeclidinium - unii:ge2t1418sv), vilanterol trifenatate (unii: 40aho2c6dg) (vilanterol - unii:028lzy775b) - umeclidinium 62.5 ug - anoro ellipta is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). limitations of use anoro ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. the safety and effectiveness of anoro ellipta in asthma have not been established. anoro ellipta is contraindicated in: risk summary there are insufficient data on the use of anoro ellipta or its individual components, umeclidinium and vilanterol, in pregnant women to inform a drug-associated risk. (see clinical considerations.) in animal reproduction studies, umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effects on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled dose (mrhdid). vilanterol administered via inhalation to pregnant rats and rabbits produced no fetal structural abnormalities at exposures approximately 70 times the mrhdid. (see data.) the estimated risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations labor or delivery: anoro ellipta should be used during late gestation and labor only if the potential benefit justifies the potential for risks related to beta-agonists interfering with uterine contractility. data animal data: the combination of umeclidinium and vilanterol has not been studied in pregnant animals. studies in pregnant animals have been conducted with umeclidinium and vilanterol individually. umeclidinium: in separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 50 and 200 times the mrhdid, respectively (on an auc basis at maternal inhalation doses up to 278 mcg/kg/day in rats and at maternal subcutaneous doses up to 180 mcg/kg/day in rabbits). no evidence of teratogenic effects was observed in either species. in a perinatal and postnatal developmental study in rats, dams received umeclidinium during late gestation and lactation periods with no evidence of effects on offspring development at doses up to approximately 26 times the mrhdid (on an auc basis at maternal subcutaneous doses up to 60 mcg/kg/day). vilanterol: in separate embryofetal developmental studies, pregnant rats and rabbits received vilanterol during the period of organogenesis at doses up to approximately 13,000 and 450 times, respectively, the mrhdid (on a mcg/m2 basis at maternal inhalation doses up to 33,700 mcg/kg/day in rats and on an auc basis at maternal inhaled doses up to 5,740 mcg/kg/day in rabbits). no evidence of structural abnormalities was observed at any dose in rats or in rabbits up to approximately 70 times the mrhdid (on an auc basis at maternal doses up to 591 mcg/kg/day in rabbits). however, fetal skeletal variations were observed in rabbits at approximately 450 times the mrhdid (on an auc basis at maternal inhaled or subcutaneous doses of 5,740 or 300 mcg/kg/day, respectively). the skeletal variations included decreased or absent ossification in cervical vertebral centrum and metacarpals. in a perinatal and postnatal developmental study in rats, dams received vilanterol during late gestation and the lactation periods at doses up to approximately 3,900 times the mrhdid (on a mcg/m2 basis at maternal oral doses up to 10,000 mcg/kg/day). no evidence of effects in offspring development was observed. risk summary there is no information available on the presence of umeclidinium or vilanterol in human milk, the effects on the breastfed child, or the effects on milk production. umeclidinium was detected in the plasma of offspring of lactating rats treated with umeclidinium suggesting its presence in maternal milk. (see data.) the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for anoro ellipta and any potential adverse effects on the breastfed child from umeclidinium or vilanterol or from the underlying maternal condition. data subcutaneous administration of umeclidinium to lactating rats at greater than or equal to 60 mcg/kg/day resulted in a quantifiable level of umeclidinium in 2 of 54 pups, which may indicate transfer of umeclidinium in rat milk. the safety and effectiveness of anoro ellipta have not been established in pediatric patients. anoro ellipta is not indicated for use in pediatric patients. based on available data, no adjustment of the dosage of anoro ellipta in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. clinical trials of anoro ellipta for copd included 2,143 subjects aged 65 years and older and 478 subjects aged 75 years and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects. patients with moderate hepatic impairment (child-pugh score of 7-9) showed no relevant increases in cmax or auc, nor did protein binding differ between subjects with moderate hepatic impairment and their healthy controls. studies in subjects with severe hepatic impairment have not been performed [see clinical pharmacology (12.3)] . there were no significant increases in either umeclidinium or vilanterol exposure in subjects with severe renal impairment (crcl <30 ml/min) compared with healthy subjects. no dosage adjustment is required in patients with renal impairment [see clinical pharmacology (12.3)] .

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - umeclidinium as bromide; vilanterol as trifenatate - powder for inhalation - vilanterol as trifenatate 22 mcg; umeclidinium as bromide 55 mcg - vilanterol and umeclidinium bromide - anoro is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).anoro ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - umeclidinium bromide, vilanterol trifenatate - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - anoro ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg;  ; vilanterol trifenatate 40ug equivalent to vilanterol 25 mcg;   - powder for inhalation - 62.5mcg/25mcg - active: umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg   vilanterol trifenatate 40ug equivalent to vilanterol 25 mcg   excipient: lactose monohydrate magnesium stearate - long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

glaxo saudi arabia, saudi arabia - vilanterol, umeclidinium bromide - inhalation powder, pre-dispensed - 25, 62.5 µg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

glaxo operation - umeclidinium bromide, vilanterol - inhalation powder, pre-dispensed - 25, 62.5 µg

Canada - English - Health Canada

glaxosmithkline inc - vilanterol (vilanterol trifenatate); umeclidinium (umeclidinium bromide) - powder - 25mcg; 62.5mcg - vilanterol (vilanterol trifenatate) 25mcg; umeclidinium (umeclidinium bromide) 62.5mcg - antimuscarinics antispasmodics

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glaxosmithkline pharmaceutical sdn. bhd. - vilanterol trifenatate; umeclidinium bromide -

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

glaxo saudi arabia, saudi arabia - umeclidinium bromide,vilanterol - inhalation powder, pre-dispensed - 62.5,25 µg,