Pajjiż: Indoneżja
Lingwa: Indoneżjan
Sors: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
OLAPARIB
ASTRAZENECA INDONESIA - Indonesia
OLAPARIB
150 Mg
TABLET SALUT SELAPUT
DUS, 7 BLISTER @ 8 TABLET SALUT SELAPUT
ABBVIE LIMITED - United States of America
2021-02-22
PROPOSED PACKAGING MATERIAL Code LYNPARZA 100 150 (56s) TAB-PI-03.01 Submission ☐ NDA ☐ Renewal ☑ Variation change detail no.: MU-104953-135498_ _ Code of previous version LYNPARZA 100 150 (56s) TAB-PI-01.02 Changes Additional Indication of PROfound Reference ☑ CDS version: V3.0 / Doc ID-004025980 ☐ CPIL version: ☑ SmPC country/version/date: EU SmPC/ Feb 2021/ Doc ID-004086888 v11. ☐ GRL approval: 24 May 2021 Name & Date MMN – 6 Jun 2022 DISETUJUI OLEH BPOM: 19/10/2022 EREG10042212200028 EREG10042212200029 LYNPARZA™ _Olaparib _ FILM-COATED TABLET 1. NAME OF THE MEDICINAL PRODUCT Lynparza™ (olaparib), 150 mg, film-coated tablets Lynparza™ (olaparib), 100 mg, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lynparza 100 mg film-coated tablets Each film-coated tablet contains 100 mg olaparib. Lynparza 150 mg film-coated tablets Each film-coated tablet contains 150 mg olaparib. Excipient with known effect: This medicinal product contains 0.24 mg sodium per 100 mg tablet and 0.35 mg sodium per 150 mg tablet, i.e. essentially “sodium-free”. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Lynparza 100 mg film-coated tablets Yellow to dark yellow, oval, bi-convex tablet, debossed with ‘OP100’ on one side and plain on the other side. Lynparza 150 mg film-coated tablets Green to green/grey, oval, bi-convex tablet, debossed with ‘OP150’ on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ovarian cancer Lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (FIGO stages III and IV) _BRCA1/2_-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer Aqra d-dokument sħiħ