IMATAB imatinib (as mesilate) 400 mg tablet bottle

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

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

Disponibil de la:

Juno Pharmaceuticals Pty Ltd

Forma farmaceutică:

Tablet, film coated

Compoziție:

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

Calea de administrare:

Oral

Unități în pachet:

30

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

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).

Rezumat produs:

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: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statutul autorizaţiei:

Registered

Data de autorizare:

2019-08-29