DASATINIB-DRLA dasatinib 100 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dasatinib propylene glycol, Quantity: 116 mg (Equivalent: dasatinib, Qty 100 mg)

Available from:

Dr Reddys Laboratories Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; hypromellose; silicon dioxide; lactose; titanium dioxide; croscarmellose sodium; magnesium stearate; triacetin; hydrogenated castor oil

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DASATINIB-DRLA is indicated for the treatment of adults aged 18 years or over with:,- newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. - Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,DASATINIB-DRLA is indicated for the treatment of paediatric patients with:,- newly diagnosed Ph+ ALL in combination with chemotherapy.

Product summary:

Visual Identification: White to off white, oval shaped tablets debossed with '603' on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-06-17