Product Dossier
PROMETRIUM
Product Dossier for PROMETRIUM (progesterone, Besins Healthcare). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Besins Healthcare
- Active ingredient: progesterone
- Therapeutic area: Reproductive Health
- Related brand: ORIPRO
- Related brand: UTROGESTAN
- Related brand: ENDOMETRIN
- Same area: ESTRADOT
- Same area: PROVERA
I cannot provide a
Brand Dossier for PROMETRIUM based on the documents supplied. The documents describe two different products:
1. **Oripro** (vaginal pessaries, 100 mg and 200 mg) — sponsored by Orion Laboratories / Evaris Pharma, first approved December 2003.
2. **PROMETRIUM** (soft capsules, 100 mg and 200 mg) — sponsored by Besins Healthcare, first listed on ARTG 2016-06-20.
The source documents do not contain sufficient information about PROMETRIUM specifically to support a complete Brand Dossier. The detailed product information (sections covering indications, dosing, safety warnings, contraindications, and regulatory history) is drawn from the Oripro pessary product information, not from PROMETRIUM capsules. The ARTG entry and PBS listing confirm PROMETRIUM exists as a capsule formulation, but the clinical and safety details needed for the dossier are absent from the provided sources.
To write an accurate Brand Dossier for PROMETRIUM, I would need the Product Information document for the PROMETRIUM capsule formulation specifically.