ARTG Entry

BIJUVA

ARTG entry for BIJUVA (estradiol hemihydrate, progesterone), ARTG 367690 — Product Information, dosage form, registration history. Compiled by arcimedes.

What it is

BIJUVA is a capsule containing estradiol (as hemihydrate) 1 mg and progesterone 100 mg.

Approved indications

— Continuous combined hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women with an intact uterus and with at least 12 months since last menses.

Dosing overview

BIJUVA 1/100 is indicated for continuous combined hormone replacement therapy. Specific dosing schedules are not detailed in the available sources.

Regulatory history

BIJUVA 1/100 received TGA approval on 2022-04-27. The product was first listed on the ARTG on 2022-05-03.

TGA Public Summary — ARTG 367690