Krajina: Indonézia
Jazyk: indonézština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LORLATINIB
PFIZER INDONESIA - Indonesia
LORLATINIB
100.000 MG
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT
PFIZER MANUFACTURING DEUTSCHLAND GMBH - Federal Republic of Germany
2022-03-21
Generic Name: Lorlatinib Trade Name: LORLAK ® CDS Effective Date: November 11, 2020 Supersedes: September 11, 2020 Approved by BPOM: 2019-0057286; 2020-0064623 Page 1 of 28 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Lorlatinib Trade Name: LORLAK ® CDS Effective Date: November 11, 2020 Supersedes: September 11, 2020 1. NAME OF THE MEDICINAL PRODUCT 1.1. PRODUCT NAME LORLAK ® 1.2. STRENGTH 25 mg and 100 mg 1.3. PHARMACEUTICAL DOSAGE FORM Film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 mg film-coated tablet contains 25 mg of lorlatinib. Each 100 mg film-coated tablet contains 100 mg of lorlatinib. For the full list of excipients, see Section 6.1. STRUCTURE O N O M e M e N N M e C N N H 2 N F R 3. PHARMACEUTICAL FORM 25 mg: Round light pink film-coated tablet, debossed with “Pfizer” on one side and “25” and “ LLN” on the other side. 100 mg: Oval dark pink film-coated tablet, debossed with “Pfizer” on one side and “LLN 100” on the other side. DISETUJUI OLEH BPOM: 28/02/2023 ID: EREG10024112200622 EREG10024112200623 Generic Name: Lorlatinib Trade Name: LORLAK ® CDS Effective Date: November 11, 2020 Supersedes: September 11, 2020 Approved by BPOM: 2019-0057286; 2020-0064623 Page 2 of 28 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS LORLAK ® as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. LORLAK ® is indicated for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after previously treated with one or more ALK tyrosine kinase inhibitors (TKIs). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Treatment with lorlatinib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. ALK testing ALK-positive status should be established using a validated ALK assay. Detection of ALK positive NSCLC is neces Prečítajte si celý dokument