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

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.

European Union - English - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - atosiban (as acetate) - premature birth - other gynecologicals - tractotile 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ferring pharmaceuticals ltd - atosiban acetate - solution for infusion - 7.5mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ferring pharmaceuticals ltd - atosiban acetate - solution for injection - 7.5mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sun pharmaceutical industries europe b.v. - atosiban acetate - solution for infusion - 7.5mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sun pharmaceutical industries europe b.v. - atosiban acetate - solution for injection - 7.5mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bowmed ibisqus ltd - atosiban acetate - solution for infusion - 7.5mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bowmed ibisqus ltd - atosiban acetate - solution for infusion - 7.5mg/1ml

Malta - English - Medicines Authority

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