IMATINIB RAN imatinib (as mesilate) 100 mg tablet bottle pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

imatinib mesilate, Quantity: 119.5 mg

זמין מ:

Sun Pharma ANZ Pty Ltd

INN (שם בינלאומי):

imatinib mesilate

טופס פרצבטיות:

Tablet, film coated

הרכב:

Excipient Ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

100

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

? 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: Dark yellow to brownish-orange, film-coated, round tablets, debossed with 'I' and '1' on either side of break line on one side and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

מצב אישור:

Licence status A

תאריך אישור:

2015-11-26