APOTEX-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack

Active ingredient:

varenicline tartrate, Quantity: 1.71 mg (Equivalent: varenicline, Qty 1 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

varenicline tartrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; calcium hydrogen phosphate; hypromellose; triacetin; hyprolose; titanium dioxide; indigo carmine aluminium lake; magnesium stearate

Administration route:

Oral

Units in package:

11 x 0.5 mg tablets and 42 x 1 mg tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

Product summary:

Visual Identification: Blue, modified capsule-shaped, biconvex, film coated tablet engraved "APO" on one side, "VAR" over"1" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 12 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-04-03