ARTG Entry
ZOELY
ARTG entry for ZOELY (nomegestrol acetate, estradiol), ARTG 168332 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Theramex
- Active ingredient: nomegestrol acetate, estradiol
- Therapeutic area: Reproductive Health
What it is
ZOELY is a tablet containing nomegestrol acetate 2.5 mg and estradiol 1.5 mg.
Approved indications
— Oral contraception.
Key safety warnings
Estrogens and progestogens should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during treatment with conjugated estrogens combined with medroxyprogesterone acetate relative to placebo. Estrogen and estrogen/progestogen therapy has been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism. The use of estrogen–progestogen by women has been shown to increase the risk of breast cancer that is dependent on the duration of taking hormone replacement therapy, becoming apparent after about three years. A two to four fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.
Regulatory history
The TGA approved the registration of Zoely for oral contraception on 10 August 2011. The product was first listed on the Australian Register of Therapeutic Goods on 15 August 2011. In November 2017, the PBAC recommended the medicine for oral contraception.