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

besins healthcare (uk) ltd - dienogest - oral tablet - 2mg

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - dienogest - tablets - 2 milligram - pregnadien derivatives

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - dienogest; ethinylestradiol - film-coated tablet - 2.0 mg/0.03 milligram(s) - progestogens and estrogens, fixed combinations; dienogest and estrogen

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

laboratoires bailleul s.a. - dienogest 2 mg (white tablet); ethinylestradiol 0,03 mg (white tablet); placebo (pink tablet) - film-coated tablet - 2 mg - 0,03 mg - dienogest 2 mg; ethinylestradiol 0.03 mg; placebo - dienogest and estrogen; g03aa16 dienogest and ethinylestradiol

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

physicians total care, inc. - estradiol valerate (unii: okg364o896) (estradiol valerate - unii:okg364o896) - estradiol valerate 3 mg - natazia™ is indicated for use by women to prevent pregnancy. the efficacy of natazia in women with a body mass index (bmi) of > 30 kg/m2 has not been evaluated. do not prescribe natazia to women who are known to have the following: - 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 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 [see warnings and precautions (5.

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

bayer healthcare pharmaceuticals inc. - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate 3 mg - natazia® is indicated for use by women to prevent pregnancy. the efficacy of natazia in women with a body mass index (bmi) of > 30 kg/m2 has not been evaluated. natazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see clinical studies (14.2)]. natazia is contraindicated in females who are known to have or develop the following conditions: 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. the administration of cocs to induce withdrawal bleeding should not be used as a test for pregnancy. cocs should not be used during pregnancy to treat threatened or habitual abortion. wo

Canada - English - Health Canada

bayer inc - dienogest - tablet - 2mg - dienogest 2mg - progestins

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

bayer australia ltd - estradiol valerate, quantity: 3 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; povidone; purified talc; maize starch - oral contraception. treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who desire oral contraception.

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - dienogest micronized; ethinylestradiol micronized - film-coated tablet - 2 mg/0.03 milligram(s) - progestogens and estrogens, fixed combinations; dienogest and estrogen

Ireland - English - HPRA (Health Products Regulatory Authority)

gedeon richter plc - dienogest; ethinylestradiol - film-coated tablet - 2mg/0.03 milligram(s) - progestogens and estrogens, fixed combinations; dienogest and ethinylestradiol