Country: Ġordan
Lingwa: Ingliż
Sors: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)
Imatinib 400 mg
شركة مستودع الأدوية الأردني - The Jordan Drugstore Co
L01XE01
Imatinib 400 mg
400 mg
30
NOVARTIS PHARMA STEIN AG /SWI (سويسرا)
GLIVEC ® 1. NAME OF THE MEDICINAL PRODUCT Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Glivec 100 mg film-coated tablets Each film-coated tablet contains 100 mg imatinib (as mesilate). Glivec 400 mg film-coated tablets Each film-coated tablet contains 400 mg imatinib (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Glivec 100 mg film-coated tablets Very dark yellow to brownish-orange film-coated tablet, round, biconvex with bevelled edges, with “NVR” on one side and “SA” and score on the other side. Glivec 400 mg film-coated tablets Very dark yellow to brownish-orange, ovaloid, biconvex film-coated tablet with bevelled edges, debossed with “NVR” on one side and “SL” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glivec is indicated for the treatment of • adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. • adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. • adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. • adult patients with relapsed or refractory Ph+ ALL as monotherapy. • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR a rearrangement. The effect of Glivec on the outcome of bone marrow transplantation has not been determined. Glivec is indicated for • the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic Aqra d-dokument sħiħ