Australia - English - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - estetrol monohydrate, quantity: 15 mg (equivalent: estetrol, qty 14.2 mg); drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: magnesium stearate; titanium dioxide; hypromellose; hyprolose; purified talc; hydrogenated cottonseed oil; lactose monohydrate; maize starch - nextstellis is indicated for use by women of reproductive potential to prevent pregnancy.

European Union - English - EMA (European Medicines Agency)

estetra sprl - estetrol monohydrate, drospirenone - contraceptives, oral - sex hormones and modulators of the genital system, - oral contraception.the decision to prescribe lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (vte), and how the risk of vte with lydisilka compares with other combined hormonal contraceptives (chcs) (see sections 4.3 and 4.4).

European Union - English - EMA (European Medicines Agency)

gedeon richter plc. - drospirenone, estetrol monohydrate - contraceptives, oral - sex hormones and modulators of the genital system, - oral contraceptive

Canada - English - Health Canada

searchlight pharma inc - estetrol monohydrate; drospirenone - tablet - 15mg; 3mg - estetrol monohydrate 15mg; drospirenone 3mg - contraceptives

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

mayne pharma - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), estetrol monohydrate (unii: kc3gi9um9v) (estetrol - unii:enb39r14vf) - nextstellis is indicated for use by females of reproductive potential to prevent pregnancy. limitations of use nextstellis may be less effective in females with a bmi ≥ 30 kg/m2 . in females with bmi ≥ 30 kg/m2 , decreasing effectiveness may be associated with increasing bmi [see clinical studies (14)]. nextstellis is contraindicated in females who are known to have or develop the following conditions: - a history of, increased risk for, or current arterial or venous thrombotic/thromboembolic diseases. examples include females who are known to: - smoke, if 35 years of age and older [see boxed warning and warnings and precautions (5.1)] - have current or history of deep vein thrombosis or pulmonary embolism [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 v

Israel - English - Ministry of Health

dexcel ltd, israel - drospirenone; estetrol as monohydrate - film coated tablets - drospirenone 3 mg; estetrol as monohydrate 14.2 mg - drospirenone and estetrol - nextela is indicated for oral contraception

Bangladesh - English - DGDA (Directorate General of Drug Administration)

nuvista pharma ltd - drospirenone + estetrol - tablet - 3 mg + 14.2 mg

Bangladesh - English - DGDA (Directorate General of Drug Administration)

renata limited - drospirenone + estetrol - tablet - 3 mg + 14.2 mg

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

teva pharmaceuticals usa, inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone 100 mg - progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. they are also indicated for use in secondary amenorrhea. progesterone capsules should not be used in women with any of the following conditions: 1. progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. 2. undiagnosed abnormal genital bleeding. 3. known, suspected, or history of breast cancer. 4. active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. 6. known liver dysfunction or disease. 7. known or suspected pregnancy.

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

avkare, inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone 100 mg - progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. they are also indicated for use in secondary amenorrhea. progesterone capsules should not be used in women with any of the following conditions: - progesterone capsules should not be used in patients with known hypersensitivity to itsingredients. progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - active deep vein thrombosis, pulmonary embolism or history of these conditions. - active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. - known liver dysfunction or disease. - known or suspected pregnancy.