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

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

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

Предлага се от:

Juno Pharmaceuticals Pty Ltd

Лекарствена форма:

Tablet, film coated

Композиция:

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

Начин на приложение:

Oral

Броя в опаковка:

30

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

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).

Каталог на резюме:

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

Статус Оторизация:

Registered

Дата Оторизация:

2019-08-29