ARTG Entry
NUVARING
ARTG entry for NUVARING (ethinylestradiol, etonogestrel), ARTG 381186 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Organon Pharma
- Active ingredient: ethinylestradiol, etonogestrel
- Therapeutic area: Reproductive Health
What it is
NuvaRing is a vaginal drug delivery system containing etonogestrel 11.7 mg and ethinylestradiol 2.7 mg.
Approved indications
— Contraception.
Key safety warnings
The use of any combined hormonal contraceptive increases the risk of venous thromboembolism (VTE) compared with no use. The risk is highest in the first ever year of use and there is some evidence that the risk is increased when a combined hormonal contraceptive is restarted after a break in use of 4 weeks or more. VTE associated with combined hormonal contraceptive use is rare in average-risk women. The risk in pregnancy (5–20 per 10,000 women over 9 months) and the risk in the postpartum period (45–65 per 10,000 women over 12 weeks) is higher than that associated with combined hormonal contraceptive use. Women should be informed of the symptoms of VTE and seek urgent medical attention if symptoms develop. Symptoms of deep vein thrombosis can include unilateral swelling of the leg and/or foot or along a vein in the leg, pain or tenderness in the leg which may be felt only when standing or walking, increased warmth in the affected leg, and red or discoloured skin on the leg. Symptoms of pulmonary embolism can include sudden onset of unexplained shortness of breath or rapid breathing, sudden coughing which may be associated with haemoptysis, sharp chest pain or sudden severe pain in the chest which may increase with deep breathing, severe light-headedness or dizziness, and rapid or irregular heartbeat. Epidemiological studies have associated the use of combined hormonal contraceptives with an increased risk for arterial thromboembolism (such as myocardial infarction, angina pectoris, stroke or transient ischaemic attack). Arterial thromboembolic events may be fatal. The risk of arterial thromboembolic complications increases in women with risk factors. NuvaRing is intended to prevent pregnancy. It does not protect against sexually transmitted infections, including HIV infections (AIDS).
Contraindications
NuvaRing should not be used in the presence of current venous thromboembolism (on anticoagulants) or history of deep venous thrombosis or pulmonary embolism. Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, and protein S deficiency, are contraindications. Current arterial thromboembolism or history thereof (such as myocardial infarction or stroke) or prodromal condition (such as angina pectoris or transient ischaemic attack) are contraindications. History of migraine with focal neurological symptoms is a contraindication. Presence or history of severe hepatic disease as long as liver function values have not returned to normal is a contraindication. Known or suspected malignant conditions of the genital organs, the breasts, or other organs, if sex steroid-influenced, are contraindications. Undiagnosed vaginal bleeding and known or suspected pregnancy are contraindications.
Regulatory history
NuvaRing was first listed on the Australian Register of Therapeutic Goods on 29 March 2022. In May 2025, the Pharmaceutical Benefits Scheme Advisory Committee recommended NuvaRing for contraception.