Land: Indonesia
Språk: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BRIGATINIB
TAKEDA INDONESIA - Indonesia
BRIGATINIB
180 Mg
TABLET SALUT SELAPUT
DUS, 4 BLISTER @ 7 TABLET SALUT SELAPUT
PENN PHARMACEUTICAL SERVICES LIMITED - United Kingdom
2020-04-01
1 ALUNBRIG BRIGATINIB 30 MG, 90 MG & 180 MG TABLET This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Alunbrig 30 mg film-coated tablets Alunbrig 90 mg film-coated tablets Alunbrig 180 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Alunbrig 30 mg film-coated tablets Each film-coated tablet contains 30 mg of brigatinib. _Excipient with known effect_ Each film-coated tablet contains 56 mg of lactose monohydrate. Alunbrig 90 mg film-coated tablets Each film-coated tablet contains 90 mg of brigatinib. _Excipient with known effect_ Each film-coated tablet contains 168 mg of lactose monohydrate. Alunbrig 180 mg film-coated tablets Each film-coated tablet contains 180 mg of brigatinib. _Excipient with known effec_ t Each film-coated tablet contains 336 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Alunbrig 30 mg film-coated tablets Round, white to off-white film-coated tablet of approximately 7 mm in diameter with debossed “U3” on one side and plain on the other side. Alunbrig 90 mg film-coated tablets Oval, white to off-white film-coated tablet of approximately 15 mm in length with debossed “U7” on one side and plain on the other side. Alunbrig 180 mg film-coated tablets Oval, white to off-white film-coated tablet of approximately 19 mm in length with debossed “U13” on one side and plain on the other side. DISETUJUI BPOM : 17/03/2020 ID : EREG10023511900062; EREG10023511900063 EREG10023511900064; EREG10023511900065 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non squamous non-small cell lung cancer (NSCLC) progressed with crizotinib. 4.2 POSOLOG Les hele dokumentet