GENRX IMATINIB

Active ingredient:

imatinib mesilate, Quantity: 119.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

imatinib mesilate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; colloidal anhydrous silica; hypromellose; hyprolose; macrogol 8000; iron oxide red; iron oxide yellow; magnesium stearate

Administration route:

Oral

Units in package:

180, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

- treatment of patients with chronic myeloid leukaemia (CML) - treatment of adult 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).

Product summary:

Visual Identification: Brownish orange, round biconvex, bevelled-edge, film-coated tablets. Engraved "IMA" over score "100" on one side, "APO" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-04-18