BOSULIF bosutinib 500 mg tablet blister pack

Active ingredient:

bosutinib monohydrate, Quantity: 516.98 mg (Equivalent: bosutinib, Qty 500 mg)

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

bosutinib monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; povidone; poloxamer; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

30, 28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BOSULIF (bosutinib monohydrate) is indicated for the treatment of chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myeloid Ieukaemia (CML) in adult patients previously treated with two or more tyrosine kinase inhibitors

Product summary:

Visual Identification: Red, oval biconvex, film coated tablets debossed with "Pfizer" on one side and "500" on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-04-29