País: Indonèsia
Idioma: indonesi
Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
IMATINIB MESILATE
NOVARTIS INDONESIA - Indonesia
IMATINIB MESILATE
119.500 MG
TABLET SALUT SELAPUT
DUS, 6 BLISTER @ 10 TABLET SALUT SELAPUT
NOVARTIS PHARMA PRODUKTIONS GMBH - Federal Republic of Germany
2021-03-28
GLIVEC (IMATINIB MESILATE) 100 mg and 400 mg Film-coated Tablets LEAFLET DISETUJUI OLEH BPOM: 05/03/2021 EREG100005VR12000177 TRADE NAMES FILM-COATED TABLETS GLIVEC 100 mg and 400 mg film-coated tablets DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS Film-coated tablets. 100 MG TABLETS, DIVISIBLE Very dark yellow to brownish orange film-coated tablets, biconvex with debossed “NVR” on one side and “SA” and score on the other side. 400 MG TABLETS, NOT DIVISIBLE Very dark yellow to brownish orange, ovaloid, biconvex with bevelled edges. Debossed with “NVR” on one side and “SL” on the other side. ACTIVE SUBSTANCE FILM COATED TABLETS Each film-coated tablet contains 100 or 400 mg imatinib (as mesilate beta crystals). EXCIPIENTS 100 AND 400 MG (DIVISIBLE OR NON-DIVISIBLE) FILM-COATED TABLETS Tablet content: Cellulose microcrystalline, Crospovidone, Hypromellose, Magnesium stearate, Silica colloidal anhydrous. Coating content: Hypromellose, Macrogol, Talc, Iron oxide red (E172), Iron oxide yellow (E172). DISETUJUI OLEH BPOM: 05/03/2021 EREG100005VR12000177 INDICATIONS Glivec ® is indicated for the • treatment of patients with newly diagnosed Philadelphia chromosome (BCR-ABL) positive (Ph+) chronic myeloid leukaemia (CML), as well as for the treatment of patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy or in accelerated phase or blast crisis. • treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). • treatment of adult and pediatric above 1 year of age 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. • treatment of adult patients with sy Llegiu el document complet