United States - English - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy) - norgestimate and ethinyl estradiol tablets usp are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)]. norgestimate and ethinyl estradiol tablets is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.4)] have diabetes mellitus with vascular disease [see warnings and precautions (5.6)] have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.7)] women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] - have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] - have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] - have cerebrovascular disease [see warnings and precautions (5.1)] - have coronary artery disease [see warnings and precautions (5.1)] - have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] - have uncontrolled hypertension [see warnings and precautions (5.4)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.6)] - have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.7)] - women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.8)] - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.9) and use in specific populations (8.1)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[see warnings and precautions (5.11)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings and precautions ( 5.3)] there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. do not administer cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. cocs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of norgestimate and ethinyl estradiol tablets have been established in women of reproductive age. efficacy is expected to be the same for post pubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. norgestimate and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population. the pharmacokinetics of norgestimate and ethinyl estradiol tablets has not been studied in subjects with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with hepatic impairment. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal and coc causation has been excluded. [see contraindications (4) and warnings and precautions (5.2).] the pharmacokinetics of norgestimate and ethinyl estradiol tablets has not been studied in women with renal impairment.

Ireland - English - HPRA (Health Products Regulatory Authority)

consilient health limited - norgestimate; ethinylestradiol - tablet - 250 / 35 microgram(s) - progestogens and estrogens, fixed combinations; norgestimate and ethinylestradiol - progestogens and estrogens, fixed combinations - hormonal contraception

Ireland - English - HPRA (Health Products Regulatory Authority)

gedeon richter plc - norgestimate; ethinylestradiol - tablet - progestogens and estrogens, fixed combinations; norgestimate and ethinylestradiol

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

gedeon richter (uk) ltd - norgestimate; ethinylestradiol - oral tablet - 250microgram ; 35microgram

United Kingdom - English - myHealthbox

janssen-cilag ltd - norgestimate, ethinylestradiol - film-coated tablet - 35/ 250 micrograms - hormonal contraceptives for systemic use; progestogens and estrogens, fixed combinations - contraception and the recognised indications for such estrogen/progestogen combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - etonogestrel; ethinylestradiol ph.eur. - vaginal delivery system - 0.120/0.015 milligram(s) - intravaginal contraceptives; vaginal ring with progestogen and estrogen

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone; ethinylestradiol - film-coated tablet - 0.02/3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - ethinylestradiol 2.7mg (15µg/24h elution rate in-vivo);  ; etonogestrel 11.7mg (120µg/24h elution rate in-vivo);   - vaginal ring - 120mcg etonogestrel, 15mcg ethinylestradiol / 24h - active: ethinylestradiol 2.7mg (15µg/24h elution rate in-vivo)   etonogestrel 11.7mg (120µg/24h elution rate in-vivo)   excipient: evatane 1020 vn3 ethylene/vinyl acetate co-polymer evatane 28-25 ethylene/vinyl acetate co-polymer magnesium stearate - contraception.

Israel - English - Ministry of Health

bayer israel ltd - ethinylestradiol; gestodene - coated tablets - ethinylestradiol 0.03 mg; gestodene 0.075 mg - ethinylestradiol - ethinylestradiol - hormonal contraception.

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - desogestrel micronized, ethinylestradiol micronized - film coated tablet - 150/20 microgram - progestogens and estrogens, fixed combinations