Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ABEMACICLIB
PYRIDAM FARMA TBK - Indonesia
ABEMACICLIB
100 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 7 TABLET SALUT SELAPUT
LILLY DEL CARIBE, INC. - United States of America
2020-12-29
Yulareb_ID_New indication eBC_leaflet for doctor_proposed TC_V5 Page 1 of 23 YULAREB ABEMACICLIB 50, 100, 150 MG 1. NAME OF THE MEDICINAL PRODUCT Yulareb 50 mg film-coated tablets Yulareb 100 mg film-coated tablets Yulareb 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Yulareb 50 mg film-coated tablets Each film-coated tablet contains 50 mg abemaciclib. _Excipients with known effect _ Each film-coated tablet contains 14 mg of lactosemonohydrate. Yulareb 100 mg film-coated tablets Each film-coated tablet contains 100 mg abemaciclib. _Excipients with known effect _ Each film-coated tablet contains 28 mg of lactose monohydrate. Yulareb 150 mg film-coated tablets Each film-coated tablet contains 150 mg abemaciclib. _Excipients with known effect _ Each film-coated tablet contains 42 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Yulareb 50 mg film-coated tablets Beige, oval tablet of 5.2 x 9.5 mm, debossed with “Lilly” on one side and “50” on the other. Yulareb 100 mg film-coated tablets White, oval tablet of 6.6 x 12.0 mm, debossed with “Lilly” on one side and “100” on the other. Yulareb 150 mg film-coated tablets DISETUJUI OLEH BPOM : 06/02/2023 EREG10019312200043 EREG10019312200044 EREG10019312200045 Yulareb_ID_New indication eBC_leaflet for doctor_proposed TC_V5 Page 2 of 23 Yellow, oval tablet of 7.5 x 13.7 mm, debossed with “Lilly” on one side and “150” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Early Breast Cancer Yulareb in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) is indicated for the adjuvant treatment of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2−), node-positive early breast cancer at high risk of recurrence. High risk of recurrence was defined by clinical and pathological features: either ≥4 pALN (positive axillary lymph nodes), or 1-3 pALN and at least one of the following c Baca dokumen lengkapnya