País: Singapur
Idioma: inglés
Fuente: HSA (Health Sciences Authority)
IMATINIB MESYLATE 119.5 mg EQV IMATINIB BASE
NOVARTIS (SINGAPORE) PTE LTD
L01EA01
100 mg
TABLET, FILM COATED
IMATINIB MESYLATE 119.5 mg EQV IMATINIB BASE 100 mg
ORAL
Prescription Only
Novartis Pharma Stein AG
ACTIVE
2007-05-21
GLIVEC Protein-tyrosine kinase inhibitor DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS Film-coated tablets 100 MG TABLETS, DIVISIBLE: Very dark yellow to brownish orange film-coated tablets, round with imprint “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 beveled edges. Debossed with “NVR” on one side and “SL” on the other side. 400 MG TABLETS, DIVISIBLE: Very dark yellow to brownish orange, ovaloid, biconvex with beveled edges. Debossed with “400” on one side and score on the other side and “SL” on each side of the score. Certain dosage strengths and dosage forms may not be available in all countries. ACTIVE SUBSTANCE FILM-COATED TABLETS Each tablet contains 100 or 400 mg imatinib (as mesilate beta crystal). 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: Iron oxide, red (E 172), Iron oxide, yellow (E 172). INDICATIONS Glivec is indicated for the treatment of adult and pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) (for pediatric use see section DOSAGE AND ADMINISTRATION). treatment of adult and pediatric patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy (for pediatric use see section DOSAGE AND ADMINISTRATION). treatment of pediatric patients with newly diagnosed Philadelphia Leer el documento completo
Glivec Mar 2022.SINv2 Page 1 of 33 GLIVEC Protein-tyrosine kinase inhibitor DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS FILM-COATED TABLETS GLIVEC 100 and 400 mg film-coated tablets Note: Glivec is known as Gleevec ® (imatinib mesilate) tablets in the US, Canada and Israel. 100 MG TABLETS, DIVISIBLE: Very dark yellow to brownish orange film-coated tablets, round with imprint “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 beveled edges. Debossed with “NVR” on one side and “SL” on the other side. 400 MG TABLETS, DIVISIBLE: Very dark yellow to brownish orange, ovaloid, biconvex with bevelled edges. Debossed with “400” on one side and score on the other side and “SL" on each side of the score. ACTIVE SUBSTANCE FILM-COATED TABLETS Each film-coated tablet contains 100 or 400 mg imatinib (as mesilate beta crystal). 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 (E 172), Iron oxide, yellow (E 172). INDICATIONS Glivec is indicated for the • treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) (for paediatric use see section DOSAGE REGIMEN AND ADMINISTRATION). • treatment of adult and paediatric patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy (for paediatric use see section DOSAGE REGIMEN AND ADMINISTRATION). Glivec Mar 2022.SINv2 Page 2 of 33 • treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy. • treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy. • treatment of adult patients with Kit+ ( Leer el documento completo