Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
Imatinib Mesylate 478.0mg Eqv Imatinib Base
NOVARTIS (SINGAPORE) PTE LTD
L01EA01
TABLET, FILM COATED
Imatinib Mesylate 478.0mg Eqv Imatinib Base 400mg
ORAL
Prescription Only
Novartis Pharma Stein AG
ACTIVE
2017-11-08
Vativio Mar 2022.SINv2 Page 1 of 32 VATIVIO Protein-tyrosine kinase inhibitor DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS Film-coated tablets VATIVIO 100 and 400 mg film-coated tablets Note: Vativio 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 Vativio 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 REGIMEN AND ADMINISTRATION). Vativio Mar 2022.SINv2 Page 2 of 32 • 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 REGIMEN AND ADMINISTRATION). • treatment of pediatric 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+ Прочетете целия документ