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

sigma pharmaceuticals plc - conjugated oestrogens - oral tablet - 625microgram

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - bazedoxifene acetate; estrogens conjugated - tablets modified release - bazedoxifene acetate 20 mg; estrogens conjugated 0.45 mg - conjugated estrogens and bazedoxifene - treatment of the following conditions in women with a uterus:• treatment of moderate to severe vasomotor symptoms associated with menopause• prevention of postmenopausal osteoporosis

Malta - English - Malta Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - estrogens conjugated - coated tablet - estrogens conjugated 1.25 mg - sex hormones and modulators of the genital system

Malta - English - Malta Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - estrogens conjugated - cream - estrogens conjugated 0.625 mg/g - sex hormones and modulators of the genital system

Malta - English - Malta Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - estrogens conjugated - coated tablet - estrogens conjugated 0.625 mg - sex hormones and modulators of the genital system

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

a-s medication solutions - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered premarin therapy is contraindicated in individuals with any of the following conditions: premarin should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. premarin should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogens have been identified in the breast milk of mothers receiving estrogen-alone therapy. caution should be exercised when premarin is administered to a nursing woman. estrogen therapy has been used for the induction of puberty in adolescents with some forms of pubertal delay. safety and effectiveness in pediatric patients have not otherwise been established. large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, which could result in short stature if treatment is initiated before the completion of physiologic puberty in normally developing children. if estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended during estrogen administration. estrogen treatment of prepubertal girls also induces premature breast development and vaginal cornification, and may induce vaginal bleeding. in boys, estrogen treatment may modify the normal pubertal process and induce gynecomastia. there have not been sufficient numbers of geriatric patients involved in studies utilizing premarin to determine whether those over 65 years of age differ from younger subjects in their response to premarin. the women's health initiative study in the whi estrogen-alone substudy (daily ce 0.625 mg-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.5)] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg]), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.5)] . the women's health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.6)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.3), and clinical studies (14.6)]. the effect of renal impairment on the pharmacokinetics of premarin has not been studied. the effect of hepatic impairment on the pharmacokinetics of premarin has not been studied.

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

centrix pharmaceutical, inc, - estrogens, esterified (unii: 3asp8q3768) (estrogens, esterified - unii:3asp8q3768), methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - estrogens, esterified 1.25 mg - covaryxt® and covaryx® h.s. are indicated in the treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (there is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) covaryxt® and covaryx® h.s. have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus (see boxed warnings). estrogens should not be used in women with any of the following conditions: - known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease. - known or suspected estrogen-dependent neoplasia. - known or suspected pregnancy (see boxed warnings). - undiagnosed abnormal genital bleeding. - active thrombophlebitis or thromboembolic disorders. - a past history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previ

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

leading pharmaceuticals, llc - estrogens, esterified (unii: 3asp8q3768) (estrogens, esterified - unii:3asp8q3768), methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - esterified estrogens and methyltestosterone full strength and esterified estrogens and methyltestosterone half strength are indicated in the treatment of: moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (there is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) esterified estrogens and methyltestosterone full strength and esterified estrogens and methyltestosterone half strength have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus (see boxed warning). estrogens should not be used in women with any of the following conditions: 1.       known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease. 2.       known or suspected estrogen-dependent neoplasia. 3.       known or suspected pregnancy (see boxed warning). 4.       undiagnosed abnormal genital bleeding. 5.       active thrombophlebitis or thromboembolic disorders. 6.       a past history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previous estrogen use (except when in treatment of breast malignancy). methyltestosterone should not be used in: 1.       the presence of severe liver damage. 2.       pregnancy and in breast-feeding mothers because of the possibility of masculinization of the female fetus or breast-fed infant.

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

syntho pharmaceuticals, inc. - estrogens, esterified (unii: 3asp8q3768) (estrogens, esterified - unii:3asp8q3768), methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - esterified estrogens and methyltestosterone full strength and esterified estrogens and methyltestosterone half strength are indicated in the treatment of: moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (there is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) esterified estrogens and methyltestosterone full strength and esterified estrogens and methyltestosterone half strength have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus (see boxed warning). estrogens should not be used in women with any of the following conditions: 1.       known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease. 2.       known or suspe

New Zealand - English - Medsafe (Medicines Safety Authority)

wyeth (nz) ltd - conjugated estrogens 1.25mg;   - tablet - 1.25 mg - active: conjugated estrogens 1.25mg   excipient: calcium sulfate carnauba wax glyceryl mono-oleate ink lactose monohydrate macrogol 20000 magnesium stearate methylcellulose microcrystalline cellulose quinoline yellow shellac stearic acid sucrose sunset yellow fcf titanium dioxide