IMATINIB SANDOZ imatinib 400mg tablet divisible blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

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

Предлага се от:

Sandoz Pty Ltd

INN (Международно Name):

imatinib mesilate

Лекарствена форма:

Tablet, film coated

Композиция:

Excipient Ingredients: colloidal anhydrous silica; crospovidone; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; iron oxide red; macrogol 4000; iron oxide yellow

Начин на приложение:

Oral

Броя в опаковка:

30 Tablets, 28 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

IMATINIB SANDOZ 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). -Treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)

Каталог на резюме:

Visual Identification: Very dark yellow to brownish orange, ovaloid biconvex with bevelled edges. Debossed with "400" on one side and score on the other and "SL" on each side of the score.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Оторизация:

Licence status A

Дата Оторизация:

2015-11-11