Active-ingredient Dossier

Estradiol Hemihydrate

Active-ingredient Dossier for Estradiol Hemihydrate (estrogen hormone replacement). Australian brands, products, PBS listings, PBAC outcomes — compiled…

What is

Estradiol Hemihydrate Estradiol Hemihydrate is an estrogen hormone replacement therapy.

Australian brands containing

Estradiol Hemihydrate — ESTRADERM MX — SANDRENA — VAGIFEM — ZUMENON — BIJUVA — ANGELIQ — ESTROFEM — TRISEQUENS

Therapeutic areas

Estradiol Hemihydrate is registered across three therapeutic areas: Reproductive Health (3 brands), Women's Health (3 brands), and Oncology (2 brands).

Sponsor landscape

The ingredient is marketed by six sponsors: Novo Nordisk Pharmaceuticals, Bayer, Theramex, Juno Pharmaceuticals, Orion Pharma (AUS), and Arrotex Pharmaceuticals.

PBS and regulatory activity

Three brands containing Estradiol Hemihydrate are PBS-listed, with the latest PBS schedule dated 1 May 2026. The most recent PBAC outcome was recorded on 1 July 2024, and the latest AusPAR was issued on 27 April 2022.