IBRANCE

البلد: أندونيسيا

اللغة: الإندونيسية

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

العنصر النشط:

PALBOCICLIB

متاح من:

PFIZER INDONESIA - Indonesia

INN (الاسم الدولي):

PALBOCICLIB

جرعة:

100.000 MG

الشكل الصيدلاني:

TABLET SALUT SELAPUT

الوحدات في الحزمة:

DUS, 1 BLISTER @ 7 TABLET SALUT SELAPUT

المصنعة من قبل:

PFIZER MANUFACTURING DEUTSCHLAND GMBH - Federal Republic of Germany

تاريخ الترخيص:

2021-09-19

خصائص المنتج

Generic Name: Palbociclib
Trade Name: Ibrance
CDS Effective Date: November 4, 2019
Supersedes: NA
Approved by BPOM:
2022-0075110
Page 1 of 31
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Palbociclib
Trade Name: Ibrance
CDS Effective Date: November 4, 2019
Supersedes: NA
1. NAME OF THE MEDICINAL PRODUCT
1.1.
PRODUCT NAME
IBRANCE
®
1.2. STRENGTH
75 mg, 100 mg, and 125 mg
1.3.
PHARMACEUTICAL DOSAGE FORM
Film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1.
QUALITATIVE DECLARATION
Each film-coated tablet contains 75 mg or 100 mg or 125 mg of
palbociclib freebase.
N
N
N
N
N
N
M
M
E
E
O
O
N
N
H
H
N
N
N
N
H
H
N
N
O
O
M
M
E
E
Palbociclib is a yellow to orange powder
with a pKa of
7.4 (the secondary piperazine
nitrogen) and 3.9 (the pyridine nitrogen).
2.2.
QUANTITATIVE DECLARATION
Excipients: see Section 6.1 (List of excipients) for the full list of
excipients.
3. PHARMACEUTICAL FORM
Ibrance 75 mg: Round light purple film-coated tablet with “Pfizer”
debossed on one tablet
face and “PBC 75” debossed on the opposite tablet face.
Ibrance 100 mg: Oval green film-coated tablet with “Pfizer”
debossed on one tablet face and
“PBC 100” debossed on the opposite tablet face.
DISETUJUI OLEH BPOM: 10/02/2023
EREG10024112200624
EREG10024112200625
EREG10024112200626
Generic Name: Palbociclib
Trade Name: Ibrance
CDS Effective Date: November 4, 2019
Supersedes: NA
Approved by BPOM:
2022-0075110
Page 2 of 31
Ibrance 125 mg: Oval
light purple film-coated tablet
with “Pfizer” debossed on one tablet
face and “PBC 125” debossed on the opposite tablet face.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
IBRANCE is
indicated
for
the
treatment
of
hormone
receptor
(HR)-positive,
human
epidermal growth factor receptor 2 (HER2)-negative locally advanced or
metastatic breast
cancer:
-
in combination with letrozole with proven diagnosis of adenocarcinoma
of the breast
with evidence of loco regionally recurrent or metastatic disease not
amenable to resection
or radiation.
-
in combination with