VATIVIO FILM COATED TABLET 400MG

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Imatinib Mesylate 478.0mg Eqv Imatinib Base

可用日期:

NOVARTIS (SINGAPORE) PTE LTD

ATC代码:

L01EA01

药物剂型:

TABLET, FILM COATED

组成:

Imatinib Mesylate 478.0mg Eqv Imatinib Base 400mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Novartis Pharma Stein AG

授权状态:

ACTIVE

授权日期:

2017-11-08

产品特点

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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).
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•
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+