GLIVEC

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

IMATINIB MESILATE

제공처:

NOVARTIS INDONESIA - Indonesia

INN (국제 이름):

IMATINIB MESILATE

복용량:

119.500 MG

약제 형태:

TABLET SALUT SELAPUT

패키지 단위:

DUS, 6 BLISTER @ 10 TABLET SALUT SELAPUT

Manufactured by:

NOVARTIS PHARMA PRODUKTIONS GMBH - Federal Republic of Germany

승인 날짜:

2021-03-28

제품 특성 요약

GLIVEC

(IMATINIB MESILATE)
100 mg and 400 mg Film-coated Tablets LEAFLET
DISETUJUI OLEH BPOM: 05/03/2021
EREG100005VR12000177
TRADE NAMES
FILM-COATED TABLETS
GLIVEC

100 mg and 400 mg film-coated tablets
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Film-coated tablets.
100 MG TABLETS, DIVISIBLE
Very dark yellow to brownish orange film-coated tablets, biconvex with
debossed “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 bevelled
edges. Debossed with
“NVR” on one side and “SL” on the other side.
ACTIVE SUBSTANCE
FILM COATED TABLETS
Each film-coated tablet contains 100 or 400 mg imatinib (as mesilate
beta crystals).
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 (E172),
Iron oxide yellow
(E172).
DISETUJUI OLEH BPOM: 05/03/2021
EREG100005VR12000177
INDICATIONS
Glivec
®
is indicated for the
•
treatment
of
patients
with
newly
diagnosed
Philadelphia
chromosome
(BCR-ABL)
positive (Ph+) chronic myeloid leukaemia (CML), as well as for the
treatment of patients
with Ph+ CML in chronic phase after failure of interferon-alpha
therapy or in accelerated
phase or blast crisis.
•
treatment of adult patients with Kit (CD 117) positive unresectable
and/or metastatic
malignant gastrointestinal stromal tumours (GIST).
•
treatment of adult and pediatric above 1 year of age patients with
newly diagnosed
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+
ALL) integrated
with chemotherapy.
•
treatment of adult patients with relapsed or refractory Ph+ ALL as
monotherapy.
•
treatment of adult patients with myelodysplastic/myeloproliferative
diseases (MDS/MPD)
associated with platelet-derived growth factor receptor (PDGFR) gene
re-arrangements.
•
treatment of adult patients with sy