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

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

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

Tilgængelig fra:

Juno Pharmaceuticals Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

30

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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).

Produkt oversigt:

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

Autorisation status:

Registered

Autorisation dato:

2019-08-29