IMATIQUAL imatinib 400 mg film-coated tablets blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

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

Διαθέσιμο από:

Teva Pharma Australia Pty Ltd

INN (Διεθνής Όνομα):

imatinib mesilate

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

30 film-coated tablets, 90 film-coated tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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).

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2016-06-10