BOSULIF bosutinib 500 mg tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

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

Dostupné z:

Pfizer Australia Pty Ltd

INN (Medzinárodný Name):

bosutinib monohydrate

Forma lieku:

Tablet, film coated

Zloženie:

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

Spôsob podávania:

Oral

Počet v balení:

30, 28

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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

Prehľad produktov:

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

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2014-04-29