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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 128.5 mg (equivalent: sitagliptin, qty 100 mg); ertugliflozin pyroglutamic acid, quantity: 19.43 mg (equivalent: ertugliflozin, qty 15 mg) - tablet, film coated - excipient ingredients: magnesium stearate; sodium stearylfumarate; microcrystalline cellulose; croscarmellose sodium; calcium hydrogen phosphate; carnauba wax; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black - msd-ertugliflozin-sitagliptin (ertugliflozin and sitagliptin phosphate monohydrate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. [see 5.1 pharmacodynamic properties, clinical trials, and 4.4 special warnings and precautions for use]

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 500 mg; ertugliflozin pyroglutamic acid, quantity: 9.713 mg (equivalent: ertugliflozin, qty 7.5 mg) - tablet, film coated - excipient ingredients: crospovidone; sodium lauryl sulfate; microcrystalline cellulose; carnauba wax; povidone; magnesium stearate; titanium dioxide; hypromellose; hyprolose; iron oxide red - msd-ertugliflozin-metformin (ertugliflozin and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and metformin is appropriate. [see 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration]

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 500 mg; ertugliflozin pyroglutamic acid, quantity: 3.238 mg (equivalent: ertugliflozin, qty 2.5 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; carnauba wax; povidone; sodium lauryl sulfate; magnesium stearate; crospovidone; titanium dioxide; hypromellose; hyprolose; iron oxide red - msd-ertugliflozin-metformin (ertugliflozin and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and metformin is appropriate. [see 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration]

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 1000 mg; ertugliflozin pyroglutamic acid, quantity: 9.713 mg (equivalent: ertugliflozin, qty 7.5 mg) - tablet, film coated - excipient ingredients: sodium lauryl sulfate; povidone; magnesium stearate; crospovidone; carnauba wax; microcrystalline cellulose; titanium dioxide; hypromellose; hyprolose; iron oxide red - msd-ertugliflozin-metformin (ertugliflozin and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and metformin is appropriate. [see 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration]

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 1000 mg; ertugliflozin pyroglutamic acid, quantity: 3.238 mg (equivalent: ertugliflozin, qty 2.5 mg) - tablet, film coated - excipient ingredients: sodium lauryl sulfate; crospovidone; magnesium stearate; povidone; carnauba wax; microcrystalline cellulose; titanium dioxide; hypromellose; hyprolose; iron oxide red - msd-ertugliflozin-metformin (ertugliflozin and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and metformin is appropriate. [see 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration]

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

merck sharp & dohme (australia) pty ltd - ertugliflozin pyroglutamic acid, quantity: 6.48 mg (equivalent: ertugliflozin, qty 5 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; magnesium stearate; titanium dioxide; hypromellose; triacetin; iron oxide red; macrogol 3350 - steglatro (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:- - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents,[see 5.1 pharmacodynamic properties, clinical trials and 4.4 special warnings and precautions for use for available data on different add-on combination therapies].

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

merck sharp & dohme (australia) pty ltd - ertugliflozin pyroglutamic acid, quantity: 19.43 mg (equivalent: ertugliflozin, qty 15 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; magnesium stearate; microcrystalline cellulose; lactose monohydrate; titanium dioxide; hypromellose; triacetin; iron oxide red; macrogol 3350 - steglatro (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:- - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents,[see 5.1 pharmacodynamic properties, clinical trials and 4.4 special warnings and precautions for use for available data on different add-on combination therapies].

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:when metformin and/or a sulphonylurea (su) and one of the monocomponents of steglujan do not provide adequate glycaemic control.in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid - diabetes mellitus, type 2 - drugs used in diabetes, sodium-glucose co-transporter 2 (sglt2) inhibitors - steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.in addition to other medicinal products for the treatment of diabetes.

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

merck sharp & dohme (malaysia) sdn bhd - sitagliptin phosphate monohydrate; ertuglifozin l-pyroglutamic acid -