IMATINIB JUNO imatinib (as mesilate) 400 mg tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

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

זמין מ:

Juno Pharmaceuticals Pty Ltd

טופס פרצבטיות:

Tablet, film coated

הרכב:

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

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

30

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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).

leaflet_short:

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: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

2019-08-29