DAVIZIM

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

DACOMITINIB MONOHYDRATE

제공처:

PFIZER INDONESIA - Indonesia

INN (International Name):

DACOMITINIB MONOHYDRATE

복용량:

46.729 MG

약제 형태:

TABLET SALUT SELAPUT

패키지 단위:

DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT

Manufactured by:

PFIZER MANUFACTURING DEUTSCHLAND GMBH - Federal Republic of Germany

승인 날짜:

2020-12-29

제품 특성 요약

Generic Name: Dacomitinib
Trade Name: DAVIZIM
®
CDS Effective Date: July 20, 2020
Supersedes: February 26, 2018
Approved by BPOM:
2020-0059782
Page 1 of 24
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Dacomitinib
Trade Name: DAVIZIM
®
CDS Effective Date: July 20, 2020
Supersedes: February 26, 2018
1.
NAME OF THE MEDICINAL PRODUCT
DAVIZIM
®
15 mg film-coated tablets
DAVIZIM
®
30 mg film-coated tablets
DAVIZIM
®
45 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dacomitinib monohydrate is a kinase inhibitor with a molecular formula
of
C
24
H
25
ClFN
5
O
2
·H
2
O and a molecular weight of 487.95 Daltons (or 469.94 Daltons as
dacomitinib anhydrate). The chemical structure of dacomitinib
monohydrate is:
_ _
Dacomitinib is a white to pale yellow powder with pKa values of 5.0
and 8.5.
Each film-coated tablet contains dacomitinib monohydrate equivalent to
15 mg or 30 mg or
45 mg of dacomitinib. For the full list of excipients, see Section 6.1
(List of excipients).
3.
PHARMACEUTICAL FORM
Film-coated tablets 15 mg, 30 mg, 45 mg
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
DAVIZIM
®
as monotherapy, is indicated for the first-line treatment of adult
patients with
locally advanced or metastatic non-small cell lung cancer (NSCLC) with
epidermal growth
DISETUJUI OLEH BPOM: 12/07/2021
ID REG: EREG10024112100203 - EREG10024112100205
Generic Name: Dacomitinib
Trade Name: DAVIZIM
®
CDS Effective Date: July 20, 2020
Supersedes: February 26, 2018
Approved by BPOM:
2020-0059782
Page 2 of 24
factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution
mutations as
detected by an approved validated test.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
EGFR mutation status should be established prior to initiation of
DAVIZIM
®
therapy.
Posology
The recommended dose of DAVIZIM
®
is 45 mg taken orally once daily, until disease
progression or unacceptable toxicity occurs. DAVIZIM
®
can be taken with or without food.
Patients should be encouraged to take their dose at approximately the
s