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

northstar rx llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - setlakin is indicated for use by females of reproductive potential to prevent pregnancy. setlakin 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 females who are known to: - smoke, if over age 35 [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 valvular disease, or atrial fibrillation) [see warnings and precautions (5.1 )]. - have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1 )]. - have uncontrolled hypertension or hypertension with vascular disease [see warnings and precautions (5.4)]. - h

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

mayne pharma inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - levora 0.15/30-28 is indicated for use by females of reproductive potential to prevent pregnancy. levora 0.15/30-28 is contraindicated in females 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 (1)]. – have current or history of deep vein thrombosis or pulmonary embolism [see warnings (1)]. – have cerebrovascular disease [see warnings (1)]. – have coronary artery disease [see warnings (1)]. – have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings (1)]. – have inherited or acquired hypercoagulopathies [see warnings (1)]. – have uncontrolled hypertension or hypertension with vascular disease [see warnings (4)]. – have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-or

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

afaxys pharma, llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table i lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization and the iud, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. na - not available a depending on method (calendar, ovulation, symptothermal, post-ovulation) adapted from hatcher ra et al, contraceptive technology : 17th revised edition . ny, ny: ardent media, inc., 1998. combination oral contraceptives should not be used in women with any of the following conditions: thrombophlebitis or thromboembolic disorders. a past history of deep-vein thrombophlebitis or thromboembolic disorders. cerebral-vascular or coronary-artery disease. thrombogenic valvulopathies

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

medihealth (northern) ltd - levonorgestrel - oral tablet - 1.5mg

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

crescent pharma ltd - levonorgestrel - oral tablet - 1.5mg

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

clydesdale pharma ltd - levonorgestrel - oral tablet - 1.5mg

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

bayer sa-nv - levonorgestrel 13,5 mg; silver colloidal 6,5 mm - intrauterine delivery system - 13,5 mg - levonorgestrel 13.5 mg - plastic iud with progestogen

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

bayer sa-nv - levonorgestrel 19,5 mg - intrauterine delivery system - 19,5 mg - levonorgestrel 19.5 mg - plastic iud with progestogen

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

hra pharma france - levonorgestrel 1,5 mg - tablet - 1,5 mg - levonorgestrel 1.5 mg - hormonal contraceptives for systemic use

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - levonorgestrel - tablet - 1.5 milligram(s) - emergency contraceptives; levonorgestrel