HETINIB imatinib (as mesilate) 400 mg film-coated tablet bottle

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

imatinib mesilate, Quantity: 478 mg (Equivalent: imatinib, Qty 400 mg)

थमां उपलब्ध:

Hetero Australia Pty Ltd

फार्मास्यूटिकल फॉर्म:

Tablet, film coated

रचना:

Excipient Ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

30

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

HETINIB 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 hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) ? treament of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

उत्पाद समीक्षा:

Visual Identification: White to off-white coloured capsule shaped bevel edged scored film coated tablet debossed with H on one side and 20 on the other side, 2 and 0 separated by a score line.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

प्राधिकरण का दर्जा:

Licence status A

प्राधिकरण की तारीख:

2017-11-14