Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - atosiban - concentrate for soln for inf - 37.5 mg/5ml - atosiban - : other gynecologicals - atosiban accord injection is indicated to delay imminent pre-term birth in pregnant adult women with: - regular uterine contractions of at least 30 seconds duration at a rate of
4 per 30 minutes - a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of
50% - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - atosiban - solution for injection in pre-filled syringe - 6.75 milligram - atosiban

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - atosiban - solution for injection in pre-filled syringe - 6.75 milligram(s) - other gynecologicals; atosiban

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - atosiban acetate - solution for injection in a pre-filled syringe - atosiban acetate 6.75 mg - other gynecologicals

Malta - English - Medicines Authority

accord healthcare limited - atosiban acetate - concentrate for solution for infusion - atosiban acetate 37.5 mg - other gynecologicals

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - atosiban acetate - concentrate for solution for infusion - atosiban acetate 37.5 ml/5ml - other gynecologicals

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - atosiban - concentrate for solution for infusion - 37.5 mg/5ml - other gynecologicals; atosiban

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - atosiban (as acetate) - premature birth - other gynecologicals - atosiban is indicated to delay imminent pre-term birth in pregnant adult women with:regular uterine contractions of at least 30 seconds’ duration at a rate of ≥ 4 per 30 minutes;a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50%;a gestational age from 24 until 33 completed weeks;a normal foetal heart rate.