Israel - English - Ministry of Health

novo nordisk ltd., israel - estradiol as hemihydrate - film coated tablets - estradiol as hemihydrate 1 mg - estradiol - estradiol - hormone replacement therapy (hrt) for estrogen deficiency symptoms in postmenopausal women. prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are tolerant of , or contraindicated for other medicinal products approved for the prevention of osteoporosis. estrofem is particularly for women who have been hysterectomized and therefore do not require combined estrogen/progestagen therapy.the experience treating women older than 65 years is limited.

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

central texas community health centers - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.25 mg - previfem® (norgestimate/ethinyl estradiol tablets usp) and tri-previfem® (norgestimate/ethinyl estradiol tablets usp) are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . tri-previfem® (norgestimate/ethinyl estradiol tablets usp) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. previfem® (norgestimate/ethinyl estradiol tablets usp) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see clinical studies (14)] . do not prescribe previfem® or tri-previfem® to women who are known to have 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 [se

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

avkare - norelgestromin (unii: r0tay3x631) (norelgestromin - unii:r0tay3x631), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - zafemy ® is indicated for the prevention of pregnancy in women with a body mass index (bmi) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. limitations of use: zafemy may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. zafemy is contraindicated for use in women with bmi ≥ 30 kg/m 2  [see contraindications (4), warnings and precautions (5.1) and clinical studies (14)]. zafemy is contraindicated in females who are known to have or develop the following conditions: - at high risk of arterial or venous thromboembolic events. examples include women who: - 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 hyp

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

allergan, inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 10 mg - sarafem is indicated for the treatment of premenstrual dysphoric disorder (pmdd) [see   clinical studies (14.1) ].   the effectiveness of sarafem in long-term use (that is, for more than 6 months) has not been systematically evaluated in placebo-controlled trials. the use of sarafem for extended periods should be periodically re-evaluated for the individual patient [see   dosage and administration (2.1) ]. the use of maois intended to treat psychiatric disorders with sarafem or within 5 weeks of stopping treatment with sarafem is contraindicated because of an increased risk of serotonin syndrome. the use of sarafem within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [se e dosage and administration (2.4)  and warnings and precautions (5.2) ]. starting sarafem in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.5)

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - ethinylestradiol 30ug; levonorgestrel 150ug; ethinylestradiol 30ug; levonorgestrel 150ug - tablet - 30mcg/150mcg - active: ethinylestradiol 30ug levonorgestrel 150ug excipient: calcium carbonate glycerol glycol/butylene glycol montanate iron oxide yellow lactose monohydrate macrogol 6000 magnesium stearate povidone   purified talc   purified water starch sucrose titanium dioxide calcium carbonate erythrosine montangylycol wax (wax e pharma) (dab) lactose monohydrate macrogol 6000 magnesium stearate ponceau 4r povidone   purified talc   starch sucrose active: ethinylestradiol 30ug levonorgestrel 150ug excipient: calcium carbonate carnauba wax white wax, polishing lactose monohydrate macrogol 6000 magnesium stearate povidone   purified talc   purified water starch sucrose calcium carbonate erythrosine montangylycol wax (wax e pharma) (dab) macrogol 6000 magnesium stearate ponceau 4r povidone purified talc starlac sucrose calcium carbonate erythrosine wax e pharma lactose macrogol 6000 magnesium stearate maize starch ponceau 4r povidone   purified talc   purified water sucrose - monofeme is indicated for prevention of pregnancy.

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

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.07 mg (equivalent: estradiol, qty 2 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; purified talc; magnesium stearate; titanium dioxide; hypromellose; hyprolose; indigo carmine; macrogol 400 - short term symptomatic treatment of oestrogen deficiency due to natural or surgical menopause in hysterectomised postmenopausal women. in women with intact uteri, use of opposed therapy must be considered.

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

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 1.03 mg (equivalent: estradiol, qty 1 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; purified talc; magnesium stearate; titanium dioxide; hypromellose; hyprolose; iron oxide red; propylene glycol - short term symptomatic treatment of oestrogen deficiency due to natural or surgical menopause in hysterectomised postmenopausal women. in women with intact uteri, use of opposed therapy must be considered.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

the female health company , united kingdom - female condoms -

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

pfizer australia pty ltd - ethinylestradiol,levonorgestrel -

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

pfizer australia pty ltd - levonorgestrel, quantity: 0.15 mg; ethinylestradiol, quantity: 0.03 mg - tablet, sugar coated - excipient ingredients: povidone; lactose monohydrate; magnesium stearate; erythrosine; sucrose; purified talc; macrogol 6000; calcium carbonate; maize starch; brilliant scarlet 4r; glycol montanate - indicated for the prevention of pregnancy.