Ülke: Endonezya
Dil: Endonezce
Kaynak: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
OSIMERTINIB MESILATE
ASTRAZENECA INDONESIA - Indonesia
OSIMERTINIB MESILATE
40 MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
ASTRAZENECA Pharmaceuticals - Sweden
2018-05-24
Page 1 of 32 TAGRISSO _Osimertinib _ FILM-COATED TABLET 1. NAME OF THE MEDICINAL PRODUCT TAGRISSO 80 mg film-coated tablets TAGRISSO 40 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 80 mg tablet contains a dose of 80 mg osimertinib (as mesylate). Each 40 mg tablet contains a dose of 40 mg osimertinib (as mesylate). For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. The TAGRISSO 80 mg tablet is a beige, 7.25 x 14.5 mm, oval, biconvex tablet, debossed with “AZ” and “80” on one side and plain on the reverse. The TAGRISSO 40 mg tablet is a beige, 9 mm, round, biconvex tablet, debossed with “AZ” and “40” on one side and plain on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TAGRISSO (osimertinib) is indicated for: • the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. • the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC) who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with TAGRISSO should be initiated by a physician experienced in the use of anticancer therapies. When considering the use of TAGRISSO, EGFR mutation status in tumour or plasma specimens DISETUJUI OLEH BPOM: 30/06/2021 ID: EREG100422VR12100032 EREG100422VR12100037 EREG100422VR12100040 EREG100422VR12100041 Page 2 of 32 should be determined using a validated test method (see section 4.4) for: • exon 19 deletions or exon 21 (L858R) substitution mutations (for first-line treatment) • T790M mutations (following progression on or after EGFR TKI therapy). Posology The recommended dose of TAGRISSO is 80 mg osimertinib once a day until disease progression or unacceptable toxicity. Missed dose If a dose of Belgenin tamamını okuyun