IMATAB imatinib (as mesilate) 400 mg tablet bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

imatinib mesilate, Quantity: 477.88 mg (Equivalent: imatinib, Qty 400 mg)

Disponible des:

Juno Pharmaceuticals Pty Ltd

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: sodium stearylfumarate; hypromellose; purified talc; iron oxide yellow; iron oxide red

Vía de administración:

Oral

Unidades en paquete:

30

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

The proposed Imatinib tablet is indicated for the:,? treatment of patients with chronic myeloid leukaemia (CML),? treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, where conventional therapies have failed,? treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed,? treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL),? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Resumen del producto:

Visual Identification: Brownish, oval, biconvex, film coated tablet debossed with "400" on one side, scoreline on other side and "N" & "I" on either sides of this scoreline; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Estat d'Autorització:

Registered

Data d'autorització:

2019-08-29