VATIVIO FILM COATED TABLET 400MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Imatinib Mesylate 478.0mg Eqv Imatinib Base

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

L01EA01

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Imatinib Mesylate 478.0mg Eqv Imatinib Base 400mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharma Stein AG

Authorization status:

ACTIVE

Authorization date:

2017-11-08

Summary of Product characteristics

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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+