Product Dossier
MIRENA
Product Dossier for MIRENA (levonorgestrel, Bayer). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Bayer
- Active ingredient: levonorgestrel
- Therapeutic area: Reproductive Health
- Related brand: MICROLUT
- Related brand: KYLEENA
- Related brand: LEVONORGESTREL-1
- Same area: ORIPRO
- Same area: DEPO-PROVERA
What it is
Mirena is a levonorgestrel 52 mg intrauterine drug delivery system.
Approved indications
— Contraception.
Dosing overview
Mirena delivers 52 mg of levonorgestrel as an intrauterine system.
PBS listing
Mirena 52 mg intrauterine drug delivery system is listed on the PBS with 2 items under a restricted restriction, at an ex-manufacturer price of A$162.33.
Regulatory history
Mirena was first listed on the ARTG on 24 July 2000. In November 2017, the PBAC recommended an amendment to the PBS listing to allow the levonorgestrel intrauterine system to be used for contraception.