IMATIQUAL imatinib 400 mg film-coated tablets blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

imatinib mesilate, Quantity: 477.877 mg (Equivalent: imatinib, Qty 400 mg)

Disponible desde:

Teva Pharma Australia Pty Ltd

Designación común internacional (DCI):

imatinib mesilate

formulario farmacéutico:

Tablet, film coated

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

30 film-coated tablets, 90 film-coated tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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).

Resumen del producto:

Visual Identification: Imatinib tablets 400 mg are dark yellow to brownish oblong film coated tablets debossed with IT and 4 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

Estado de Autorización:

Licence status A

Fecha de autorización:

2016-06-10