European Union - English - EMA (European Medicines Agency)

gedeon richter plc. - ulipristal acetate - leiomyoma - sex hormones and modulators of the genital system, - ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.

Malta - English - Medicines Authority

g.l. pharma gmbh schlossplatz 1, 8502 lannach, austria - ulipristal acetate - tablet - ulipristal acetate 5 mg - sex hormones and modulators of the genital system

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - ulipristal acetate - film-coated tablet - 30 milligram(s) - emergency contraceptives; ulipristal

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

afaxys pharma llc - ulipristal acetate (unii: yf7v70n02b) (ulipristal - unii:6j5j15q2x8) - ulipristal acetate 30 mg - ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive. ella is contraindicated for use in the case of known or suspected pregnancy. [see use in specific populations (8.1 ).] risk summary ella is contraindicated for use during an existing or suspected pregnancy. no signal of concern regarding pregnancy complications was found in postmarketing studies [see data ]. isolated cases of major malformations in ella- exposed pregnancies were identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent use of ella during pregnancy. miscarriage was reported in 14% of the known pregnancy outcomes; a rate that is similar to the u.s background rate for miscarriage. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized p

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

vifor pharma pty ltd - ulipristal acetate -

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

orion laboratories pty ltd t/a perrigo australia - ulipristal acetate, quantity: 30 mg - tablet, uncoated - excipient ingredients: povidone; magnesium stearate; croscarmellose sodium; lactose monohydrate - ellaone is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

Israel - English - Ministry of Health

cts ltd - ulipristal acetate - tablets - ulipristal acetate 30 mg - ulipristal - ulipristal - emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

hyphens pharma sdn. bhd. - ulipristal acetate; ulipristal acetate -

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

hra pharma america, inc. - ulipristal acetate (unii: yf7v70n02b) (ulipristal - unii:6j5j15q2x8) - ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure [see dosage and administration (2.1)] . ella is not intended for routine use as a contraceptive. ella is contraindicated for use in the case of known or suspected pregnancy [see use in specific populations (8.1)]. risk summary ella is contraindicated for use during an existing or suspected pregnancy. no signal of concern regarding pregnancy complications was found in postmarketing studies [see data ]. isolated cases of major malformations in ella- exposed pregnancies were identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent use of ella during pregnancy. miscarriage was reported in 14% of the known pregnancy outcomes; a rate that is similar to the u.s. background rate for miscarriage.  in the u.s. general population, the estimated background risk of major birth defects and m

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

cenexi hsc - ulipristal acetate (unii: yf7v70n02b) (ulipristal - unii:6j5j15q2x8) - ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure [see dosage and administration (2.1)] . e lla is not intended for routine use as a contraceptive. ella is contraindicated for use in the case of known or suspected pregnancy [see use in specific populations (8.1)]. risk summary ella is contraindicated for use during an existing or suspected pregnancy. no signal of concern regarding pregnancy complications was found in postmarketing studies [see  data ]. isolated cases of major malformations in ella- exposed pregnancies were identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent use of ella during pregnancy. miscarriage was reported in 14% of the known pregnancy outcomes; a rate that is similar