Product Dossier
BIJUVA
Product Dossier for BIJUVA (estradiol hemihydrate, Theramex). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Theramex
- Active ingredient: estradiol hemihydrate
- Therapeutic area: Reproductive Health
- Related brand: ESTROGEL
- Related brand: ESTRO-PESS
- Related brand: Estraderm MX
- Same area: ORIPRO
- Same area: DEPO-PROVERA
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.