IMATIQUAL imatinib 100 mg film-coated tablets blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

imatinib mesilate, Quantity: 119.469 mg (Equivalent: imatinib, Qty 100 mg)

Доступно од:

Teva Pharma Australia Pty Ltd

INN (Међународно име):

imatinib mesilate

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol

Пут администрације:

Oral

Јединице у пакету:

180 film-coated tablets, 60 film-coated tablets

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

1) IMATIQUAL (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (CML). 2) IMATIQUAL (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. 3) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with relapsed or refractory Ph+ALL as monotherapy. 4) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements, where conventional therapies have failed. 5) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed. 6) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). 7) IMATIQUAL (imatinib) is indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) 8) IMATIQUAL (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of KIT (CD117)-positive primary GIST. 9) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Резиме производа:

Visual Identification: Imatinib tablets 100 mg are dark yellow to brownish orange round film coated tablets debossed with IT and 1 divided by score line on one side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Licence status A

Датум одобрења:

2016-06-10