TERONIB imatinib (as mesilate) 400 mg film-coated tablet bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

imatinib mesilate, Quantity: 478 mg (Equivalent: imatinib, Qty 400 mg)

Tilgængelig fra:

Hetero Australia Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc

Indgivelsesvej:

Oral

Enheder i pakken:

30

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

TERONIB 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 hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) ? treament of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Produkt oversigt:

Visual Identification: White to off-white coloured capsule shaped bevel edged scored film coated tablet debossed with H on one side and 20 on the other side, 2 and 0 separated by a score line.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorisation status:

Registered

Autorisation dato:

2017-11-14