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

glaxosmithkline llc - albiglutide (unii: 5e7u48495e) (albiglutide - unii:5e7u48495e) - albiglutide 30 mg in 0.5 ml - tanzeum is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14)]. limitations of use: tanzeum is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2) [see warnings and precautions (5.1)] . tanzeum is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components. serious hypersensitivity reactions including angioedema have been reported with tanzeum [see warnings and precautions (5.4)]. pregnancy category c there are no adequate and well-controlled studies of tanzeum in pregnant women. nonclinical studies have shown reproductive toxicity, but not teratogenicity, in mice treated with albiglutide at up to 39 times human exposure resulting from the maximum recommended dose of 50 mg/week, based on auc [see nonclinical toxicology (13.1, 13.3)]. tan

European Union - English - EMA (European Medicines Agency)

glaxosmithkline trading services limited - albiglutide - diabetes mellitus, type 2 - drugs used in diabetes - eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as:monotherapywhen diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance.add-on combination therapyin combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).

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

glaxosmithkline uk ltd - albiglutide - powder and solvent for solution for injection - 30mg

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

glaxosmithkline uk ltd - albiglutide - powder and solvent for solution for injection - 50mg

Canada - English - Health Canada

glaxosmithkline inc - albiglutide - powder for solution - 30mg - albiglutide 30mg - miscellaneous antidiabetic agents

Canada - English - Health Canada

glaxosmithkline inc - albiglutide - powder for solution - 50mg - albiglutide 50mg - miscellaneous antidiabetic agents

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

glaxo export limited - albiglutide - powder and solvent for solution for injection - 30 mg

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

glaxo export limited - albiglutide - powder and solvent for solution for injection - 50 mg

Canada - English - Health Canada

sanofi-aventis canada inc - insulin glargine; lixisenatide - solution - 100unit; 33mcg - insulin glargine 100unit; lixisenatide 33mcg - insulins

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - insulin glargine; lixisenatide - injection, solution - insulin glargine 100 units/ml; lixisenatide 33μg/ml