BOSULIF bosutinib 500 mg tablet blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

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

MAH:

Pfizer Australia Pty Ltd

INN:

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_indication:

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

leaflet_short:

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