Product Dossier
SANDRENA
Product Dossier for SANDRENA (estradiol, Orion Pharma (AUS)). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Orion Pharma (AUS)
- Active ingredient: estradiol
- Therapeutic area: Reproductive Health
- Related brand: ESTRADOT
- Related brand: Estraderm MX
- Related brand: FEMOSTON
- Same area: PROVERA
- Same area: BEMFOLA
What it is
SANDRENA is an estradiol gel containing estradiol as hemihydrate in a 0.1% concentration, supplied in sachets for transdermal application.
Approved indications
The provided source documents do not contain information about the approved indications for SANDRENA.
Dosing overview
SANDRENA is available as a transdermal gel in two strengths: 500 micrograms in a 0.5 g sachet and 1 mg (as hemihydrate) in a 1 g sachet.
PBS listing
SANDRENA is listed on the PBS in two strengths. The 500 microgram strength (0.5 g sachet) is available as 2 PBS items with mixed restriction status, at an ex-manufacturer price of A$7.92. The 1 mg strength (1 g sachet) is also available as 2 PBS items with mixed restriction status, at an ex-manufacturer price of A$11.32. Both strengths are supplied as packs of 28 sachets.
Regulatory history
SANDRENA was first registered on the ARTG on 8 April 2003, with two sachets registered in that category: the 0.5 g and 1 g sachets.