TARCEVA

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

ERLOTINIB HYDROCHLORIDE

제공처:

MENARINI INDRIA LABORATORIES - Indonesia

INN (International Name):

ERLOTINIB HYDROCHLORIDE

복용량:

163.93 MG

약제 형태:

TABLET SALUT SELAPUT

패키지 단위:

DUS,3 BLISTER @ 10 TABLET SALUT SELAPUT

Manufactured by:

DELPHARM MILANO S.R.L - Italy

승인 날짜:

2021-12-23

제품 특성 요약

_Draft_Tarceva_PI_MAT_CDS 17.0_EN_v2_
Page 1 of 19
TARCEVA
®
Erlotinib hydrochloride
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Anti-neoplastic agent
ATC code L01EB02
1.2
TYPE OF DOSAGE FORM
Film-coated tablets
1.3
ROUTE OF ADMINISTRATION
Oral
1.4
STERILE/RADIOACTIVE STATEMENT
Not applicable
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: erlotinib hydrochloride.
Each 100 mg film-coated tablet contains 100 mg erlotinib as erlotinib
hydrochloride.
Each 150 mg film-coated tablet contains 150 mg erlotinib as erlotinib
hydrochloride.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
NON-SMALL CELL LUNG CANCER
Tarceva is indicated for the first-line treatment of patients with
locally advanced or metastatic
non-small cell lung cancer (NSCLC stage IIIb/IV) with EGFR activating
mutations (exon 19
deletions or exon 21 (L858R) mutations).
Tarceva is indicated for the treatment of patients with locally
advanced or metastatic non-small cell
lung cancer after failure of at least one prior chemotherapy regimen.
When prescribing Tarceva, factors associated with prolonged survival
should be taken into account.
No survival benefit or other clinically relevant effects of the
treatment have been demonstrated in
patients with EGFR-negative tumours.
PANCREATIC CANCER
Tarceva in combination with gemcitabine is indicated for the treatment
of patients with locally
advanced, unresectable or metastatic pancreatic cancer.
When prescribing Tarceva, factors associated with prolonged survival
should be taken into account.
No survival advantage could be shown for patients with locally
advanced disease (the median overall
survival was 6.4 months in the Tarceva group compared with 6 months in
the placebo group).
DISETUJUI OLEH BPOM: 05/05/20201
ID: EREG100364VR12000424
EREG100364VR12000428
_Draft_Tarceva_PI_MAT_CDS 17.0_EN_v2_
Page 2 of 19
2.2
DOSAGE AND ADMINISTRATION
GENERAL
Tarceva treatment should be supervised by a physician experienced in
the use of anticancer
therapies.
Non-small cell lung cancer:
EGFR