Ülke: Endonezya
Dil: Endonezce
Kaynak: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DACOMITINIB MONOHYDRATE
PFIZER INDONESIA - Indonesia
DACOMITINIB MONOHYDRATE
31.153 MG
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT
PFIZER MANUFACTURING DEUTSCHLAND GMBH - Federal Republic of Germany
2020-12-29
Generic Name: Dacomitinib Trade Name: DAVIZIM ® CDS Effective Date: July 20, 2020 Supersedes: February 26, 2018 Approved by BPOM: 2020-0059782 Page 1 of 24 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Dacomitinib Trade Name: DAVIZIM ® CDS Effective Date: July 20, 2020 Supersedes: February 26, 2018 1. NAME OF THE MEDICINAL PRODUCT DAVIZIM ® 15 mg film-coated tablets DAVIZIM ® 30 mg film-coated tablets DAVIZIM ® 45 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dacomitinib monohydrate is a kinase inhibitor with a molecular formula of C 24 H 25 ClFN 5 O 2 ·H 2 O and a molecular weight of 487.95 Daltons (or 469.94 Daltons as dacomitinib anhydrate). The chemical structure of dacomitinib monohydrate is: _ _ Dacomitinib is a white to pale yellow powder with pKa values of 5.0 and 8.5. Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg or 30 mg or 45 mg of dacomitinib. For the full list of excipients, see Section 6.1 (List of excipients). 3. PHARMACEUTICAL FORM Film-coated tablets 15 mg, 30 mg, 45 mg 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS DAVIZIM ® as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth DISETUJUI OLEH BPOM: 12/07/2021 ID REG: EREG10024112100203 - EREG10024112100205 Generic Name: Dacomitinib Trade Name: DAVIZIM ® CDS Effective Date: July 20, 2020 Supersedes: February 26, 2018 Approved by BPOM: 2020-0059782 Page 2 of 24 factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an approved validated test. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION EGFR mutation status should be established prior to initiation of DAVIZIM ® therapy. Posology The recommended dose of DAVIZIM ® is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. DAVIZIM ® can be taken with or without food. Patients should be encouraged to take their dose at approximately the s Belgenin tamamını okuyun