País: Indonésia
Língua: indonésio
Origem: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PALBOCICLIB
PFIZER INDONESIA - Indonesia
PALBOCICLIB
125.000 MG
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 7 TABLET SALUT SELAPUT
PFIZER MANUFACTURING DEUTSCHLAND GMBH - Federal Republic of Germany
2021-09-19
Generic Name: Palbociclib Trade Name: Ibrance CDS Effective Date: November 4, 2019 Supersedes: NA Approved by BPOM: 2022-0075110 Page 1 of 31 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Palbociclib Trade Name: Ibrance CDS Effective Date: November 4, 2019 Supersedes: NA 1. NAME OF THE MEDICINAL PRODUCT 1.1. PRODUCT NAME IBRANCE ® 1.2. STRENGTH 75 mg, 100 mg, and 125 mg 1.3. PHARMACEUTICAL DOSAGE FORM Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1. QUALITATIVE DECLARATION Each film-coated tablet contains 75 mg or 100 mg or 125 mg of palbociclib freebase. N N N N N N M M E E O O N N H H N N N N H H N N O O M M E E Palbociclib is a yellow to orange powder with a pKa of 7.4 (the secondary piperazine nitrogen) and 3.9 (the pyridine nitrogen). 2.2. QUANTITATIVE DECLARATION Excipients: see Section 6.1 (List of excipients) for the full list of excipients. 3. PHARMACEUTICAL FORM Ibrance 75 mg: Round light purple film-coated tablet with “Pfizer” debossed on one tablet face and “PBC 75” debossed on the opposite tablet face. Ibrance 100 mg: Oval green film-coated tablet with “Pfizer” debossed on one tablet face and “PBC 100” debossed on the opposite tablet face. DISETUJUI OLEH BPOM: 10/02/2023 EREG10024112200624 EREG10024112200625 EREG10024112200626 Generic Name: Palbociclib Trade Name: Ibrance CDS Effective Date: November 4, 2019 Supersedes: NA Approved by BPOM: 2022-0075110 Page 2 of 31 Ibrance 125 mg: Oval light purple film-coated tablet with “Pfizer” debossed on one tablet face and “PBC 125” debossed on the opposite tablet face. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: - in combination with letrozole with proven diagnosis of adenocarcinoma of the breast with evidence of loco regionally recurrent or metastatic disease not amenable to resection or radiation. - in combination with Leia o documento completo