Malta - angličtina - Medicines Authority

bayer limited 1st floor the grange offices the grange brewery road stillorgan co. dublin, a94 h2k7 , ireland - drospirenone, estradiol hemihydrate - film-coated tablet - drospirenone 2 mg estradiol hemihydrate 1 mg - sex hormones and modulators of the genital system

Belgicko - angličtina - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

bayer sa-nv - drospirenone 2 mg; estradiol hemihydrate 1 mg - eq. estradiol 1 mg - film-coated tablet - 1 mg - 2 mg - drospirenone 2 mg; estradiol 1 mg - progestogens and estrogens, fixed combinations

Spojené kráľovstvo - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

bayer plc - drospirenone; estradiol hemihydrate - oral tablet - 2mg ; 1mg

Belgicko - angličtina - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

gedeon richter plc - drospirenone 2 mg; estradiol hemihydrate 1,03 mg - eq. estradiol 1 mg - film-coated tablet - 1 mg - 2 mg - estradiol hemihydrate 1.03 mg; drospirenone 2 mg - drospirenone and estrogen

Izrael - angličtina - Ministry of Health

bayer israel ltd - drospirenone; estradiol as hemihydrate - film coated tablets - drospirenone 2 mg; estradiol as hemihydrate 1 mg - estradiol - estradiol - angeliq is indicated for hormone replacement therapy (hrt) for estrogen deficiency symptoms in postmenopausal women more than 1 year post menopause. prevention of postmenopausal osteoporosis in women with an increased risk of future osteoporosis fractures.

Malta - angličtina - Medicines Authority

bayer plc - drospirenone; estradiol - film-coated tablet - drospirenone 2 mg; estradiol 1 mg - sex hormones and modulators of the genital system

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - estradiol hemihydrate, quantity: 1.033 mg (equivalent: estradiol, qty 1 mg); drospirenone, quantity: 2 mg - tablet, film coated - excipient ingredients: povidone; hypromellose; magnesium stearate; lactose monohydrate; purified talc; macrogol 6000; titanium dioxide; pregelatinised maize starch; maize starch; iron oxide red - hormone replacement therapy (hrt) for use in the short-term treatment in postmenopausal women with an intact uterus of the climacteric syndrome caused by deficient endogenous oestrogen production due to natural menopause, hypogonadism, castration or primary ovarian failure.

Írsko - angličtina - HPRA (Health Products Regulatory Authority)

bayer limited - estradiol; drospirenone - film-coated tablet - 1 mg/2 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and estrogen

Spojené kráľovstvo - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

mawdsley-brooks & company ltd - drospirenone; estradiol hemihydrate - oral tablet - 2mg ; 1mg

Spojené štáty - angličtina - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. drospirenone and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: risk summary there is no use for contraception in pregnancy; therefore, drospirenone and ethinyl estradiol tablets should be discontinued during 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 chcs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. data human data a retrospective database study of women in norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol