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

sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz), lixisenatide (unii: 74o62bb01u) (lixisenatide - unii:74o62bb01u) - insulin glargine 100 u in 1 ml - soliqua 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use : - soliqua 100/33 has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - soliqua 100/33 is not recommended for use in combination with any other product containing a glp-1 receptor agonist [see warnings and precautions (5.5)] . - soliqua 100/33 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. - soliqua 100/33 has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. - soliqua 100/33 has not been studied in combination with prandial insulin. soliqua 100/33 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.6)] . - in patients w

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin glargine,lixisenatide -

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin glargine,lixisenatide -

Israel - English - Ministry of Health

sanofi israel ltd - insulin glargine; lixisenatide - solution for injection - lixisenatide 33 mcg / 1 ml; insulin glargine 100 units / 1 ml - insulin glargine - suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without sodium-glucose co-transporter-2 (sglt-2) inhibitors

Israel - English - Ministry of Health

sanofi israel ltd - insulin glargine; lixisenatide - solution for injection - lixisenatide 50 mcg / 1 ml; insulin glargine 100 units / 1 ml - insulin glargine - suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without sodium-glucose co-transporter-2 (sglt-2) inhibitors.

European Union - English - EMA (European Medicines Agency)

sanofi winthrop industrie - insulin glargine, lixisenatide - diabetes mellitus, type 2 - drugs used in diabetes - suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without sglt-2 inhibitors.,

Philippines - English - FDA (Food And Drug Administration)

sanofi-aventis philippines, inc. - insulin glargine , lixisenatide - solution for injection (sc) - 3.64 mg (equivalent to 100 units of insulin glargine) 750 mcg per ml

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

sanofi-aventis u.s. llc - lixisenatide (unii: 74o62bb01u) (lixisenatide - unii:74o62bb01u) - lixisenatide 50 ug in 1 ml - adlyxin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use : - adlyxin has not been studied in patients with chronic pancreatitis or a history of unexplained pancreatitis. consider other antidiabetic therapies in patients with a history of pancreatitis [see warnings and precautions (5.2)] . - adlyxin should not be used in patients with type 1 diabetes mellitus. - adlyxin has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. adlyxin is contraindicated in patients with known severe hypersensitivity to lixisenatide or to any component of adlyxin. hypersensitivity reactions including anaphylaxis have occurred with adlyxin [see warnings and precautions (5.1)and adverse reactions (6.1)] . risk summary the limited available data with lixisenatide in pregnant women are not sufficient to inform a drug-associated risk of major birth defects a

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

sanofi-aventis (malaysia) sdn. bhd. - insulin glargine; lixisenatide -

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

sanofi-aventis (malaysia) sdn. bhd. - insulin glargine; lixisenatide -