Irlandia - angielski - HPRA (Health Products Regulatory Authority)

imbat limited - drospirenone; ethinylestradiol - film-coated tablet - 0.03/3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

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

bayer australia ltd - drospirenone,ethinylestradiol -

Malezja - angielski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pahang pharmacy sdn. bhd. - drospirenone; ethinylestradiol -

Belgia - angielski - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

impexeco - ethinylestradiol; drospirenone - film-coated tablet - 0,03 mg - 3 mg - ethinylestradiol 0.03 mg; drospirenone 3 mg - drospirenone and ethinylestradiol

Kanada - angielski - Health Canada

glenmark pharmaceuticals canada inc. - drospirenone; ethinyl estradiol - tablet - 3mg; 0.02mg - drospirenone 3mg; ethinyl estradiol 0.02mg - contraceptives

Belgia - angielski - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

impexeco - ethinylestradiol; drospirenone - film-coated tablet - 0,03 mg - 3 mg - ethinylestradiol 0.03 mg; drospirenone 3 mg - drospirenone and ethinylestradiol

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

bayer australia ltd - drospirenone,ethinylestradiol -

Izrael - angielski - Ministry of Health

bayer israel ltd - drospirenone; ethinylestradiol as betadex clathrate; levomefolate calcium; levomefolate calcium - film coated tablets - levomefolate calcium 0.451 mg; ethinylestradiol as betadex clathrate 0.02 mg; drospirenone 3 mg; levomefolate calcium 0.451 mg - estradiol, combinations - - oral contraception. - treatment of symptoms of premenstrual dysphoric disorder (pmdd ) in women who choose to use an oral contraceptive as their method of birth control.- treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. - in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

Izrael - angielski - Ministry of Health

bayer israel ltd - drospirenone; ethinylestradiol as betadex clathrate; levomefolate calcium; levomefolate calcium - film coated tablets - levomefolate calcium 0.451 mg; ethinylestradiol as betadex clathrate 0.03 mg; drospirenone 3 mg; levomefolate calcium 0.451 mg - estradiol, combinations - oral contraceptive. in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

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

lupin australia pty limited - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: maize starch; lactose monohydrate; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - bella is indicated for use:,? as an oral contraceptive.,? for the treatment of moderate acne vulgaris in women who seek oral contraception.,? for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of ethinylestradiol/drospirenone 20 microgram/3 mg tablets for pmdd was not assessed beyond 3 cycles. ethinylestradiol/drospirenone 20 microgram/3 mg tablets have not been evaluated for treatment of pms (premenstrual syndrome) (see section 5.1 pharmacodynamic properties ? clinical trials).