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

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

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

Disponibbli minn:

Hetero Australia Pty Ltd

Għamla farmaċewtika:

Tablet, film coated

Kompożizzjoni:

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

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

30

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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).

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2017-11-14