YULAREB

Maa: Indonesia

Kieli: indonesia

Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiivinen ainesosa:

ABEMACICLIB

Saatavilla:

PYRIDAM FARMA TBK - Indonesia

INN (Kansainvälinen yleisnimi):

ABEMACICLIB

Annos:

150 MG

Lääkemuoto:

TABLET SALUT SELAPUT

Kpl paketissa:

DUS, 2 BLISTER @ 7 TABLET SALUT SELAPUT

Valmistaja:

LILLY DEL CARIBE, INC. - United States of America

Valtuutus päivämäärä:

2020-12-29

Valmisteyhteenveto

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