Glivec Film Coated Tablet 400mg

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

IMATINIB MESYLATE EQV IMATINIB BASE

متاح من:

NOVARTIS (SINGAPORE) PTE LTD

ATC رمز:

L01EA01

جرعة:

478.00 mg eqv. 400mg Imatinib base

الشكل الصيدلاني:

TABLET, FILM COATED

تركيب:

IMATINIB MESYLATE EQV IMATINIB BASE 400 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

Novartis Pharma Stein AG

الوضع إذن:

ACTIVE

تاريخ الترخيص:

2007-05-21

نشرة المعلومات

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

خصائص المنتج

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+ (