MSD-ERTUGLIFLOZIN 15 ertugliflozin 15 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ertugliflozin pyroglutamic acid, Quantity: 19.43 mg (Equivalent: ertugliflozin, Qty 15 mg)

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate; sodium starch glycollate type A; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red; macrogol 3350

Administration route:

Oral

Units in package:

28, 7

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MSD-ERTUGLIFLOZIN (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].

Product summary:

Visual Identification: Red, triangular-shaped, film-coated tablets debossed with '702' on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2018-05-17