Land: Indonesien
Sprog: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
CRIZOTINIB
PFIZER INDONESIA - Indonesia
CRIZOTINIB
250 MG
KAPSUL
DUS, 1 BLISTER @ 10 KAPSUL
PFIZER MANUFACTURING DEUTSCHLAND Gmbh - Germany
2018-08-01
Generic Name: Crizotinib Trade Name: XALKORI CDS Effective Date: July 3, 2019 Supersedes: June 24, 2016 Approved by BPOM: 2017-0027378; 2017-0028629; 2018-0037001 Page 1 of 29 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Crizotinib Trade Name: XALKORI CDS Effective Date: July 3, 2019 Supersedes: June 24, 2016 0 B NAME OF THE MEDICINAL PRODUCT XALKORI 200 mg; XALKORI 250 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains either 200 mg or 250 mg of crizotinib. Excipients: see Section LIST OF EXCIPIENTS for a full list of excipients. Cl Cl F O N NH 2 N N NH CH 3 (_R_) Crizotinib is a white to pale yellow powder with a pKa of 9.4 (piperidinium cation) and 5.6 (pyridinium cation). PHARMACEUTICAL FORM Hard gelatin capsules CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Crizotinib is indicated for the treatment of adults with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC). Crizotinib is indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Crizotinib is indicated for the treatment of ROS1-positive advanced NSCLC. DISETUJUI OLEH BPOM: 08/09/2021 EREG10024111900186, EREG10024112000078, EREG10024111900185, EREG10024112000079, EREG10024111900187, EREG10024112000080, Generic Name: Crizotinib Trade Name: XALKORI CDS Effective Date: July 3, 2019 Supersedes: June 24, 2016 Approved by BPOM: 2017-0027378; 2017-0028629; 2018-0037001 Page 2 of 29 Crizotinib should be prescribed by a qualified healthcare professional who is experienced in the use of anti-neoplastic therapy. POSOLOGY AND METHOD OF ADMINISTRATION ALK AND ROS1 TESTING Detection of either ALK-positive or ROS1 positive NSCLC is necessary for selection of patients for treatment with crizotinib because these are the only patients for whom benefit has been shown. Assessment for either ALK-positive or ROS1 positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology bein Læs hele dokumentet