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

bayer australia ltd - dienogest, quantity: 2 mg; ethinylestradiol, quantity: 0.03 mg - tablet, sugar coated - excipient ingredients: calcium carbonate; ferric oxide; macrogol 6000; glycol montanate; glycerol; sucrose; lactose monohydrate; maize starch; povidone; titanium dioxide; purified talc; magnesium stearate - valette is indicated for use as an oral contraceptive and in the treatment of mild to moderate acne in women who seek oral contraception.

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

Ireland - English - HPRA (Health Products Regulatory Authority)

stragen nordic a/s - dienogest - film-coated tablet - 2 milligram(s) - pregnadien derivatives; dienogest

Ireland - English - HPRA (Health Products Regulatory Authority)

g&g pharmaceutical (netherlands) b.v. - dienogest - film-coated tablet - 2 milligram(s) - pregnadien derivatives; dienogest

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

arrotex pharmaceuticals pty ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: lactose; magnesium stearate; povidone; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - this medicine is indicated for use as: ? an oral contraceptive. ? treatment of moderate acne vulgaris in women who seek oral contraception. ? treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of drospirenone 3 mg /ethinylestradiol 20 ?g for pmdd was not assessed beyond 3 cycles. drospirenone 3 mg /ethinylestradiol 20 ?g has not been evaluated for treatment of pms (premenstrual syndrome), see section 5.1 pharmacodynamic properties - clinical trials.

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

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

exeltis germany gmbh - dienogest 2 mg (white tablet); ethinylestradiol 0,03 mg (white tablet); placebo (green tablet) - film-coated tablet - 2 mg - 0,03 mg - dienogest 2 mg; ethinylestradiol 0.03 mg; placebo - dienogest and ethinylestradiol

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

arrotex pharmaceuticals pty ltd - ethinylestradiol, quantity: 30 microgram; levonorgestrel, quantity: 150 microgram - tablet, film coated - excipient ingredients: povidone; magnesium stearate; lactose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - oral contraception.

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

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

lupin australia pty limited - ethinylestradiol, quantity: 30 microgram; drospirenone, quantity: 3 mg - tablet - excipient ingredients: maize starch; magnesium stearate; pregelatinised maize starch; lactose monohydrate; titanium dioxide; hypromellose; macrogol 400 - for use as an oral contraceptive