Land: Indonesien
Sprache: Indonesisch
Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ERLOTINIB HYDROCHLORIDE
MENARINI INDRIA LABORATORIES - Indonesia
ERLOTINIB HYDROCHLORIDE
109.29 MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
DELPHARM MILANO S.R.L - Italy
2021-12-23
_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 Lesen Sie das vollständige Dokument