ACCOZOLE letrozole 2.5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

letrozole, Quantity: 2.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Letrozole

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type A; maize starch; hypromellose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; macrogol 400

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for the treatment of post menopausal women with hormone receptor positive breast cancer. The safety and efficacy of neoadjuvant use of Letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease.

Product summary:

Visual Identification: Yellow, round, biconvex, film-coated tablet plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-07-19