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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ever valinject gmbh - atosiban acetate 75 mg - eq. atosiban 75 mg - concentrate for solution for infusion - 75 mg/10 ml - atosiban acetate - atosiban

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

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

Israel - English - Ministry of Health

propharm ltd - atosiban - solution for injection/ concentrate for solution for infusion - atosiban 7.5 mg / 1 ml - atosiban - atosiban altan is indicated to delay imminent pre-term birth in pregnant women with: - regular uterine contractions of at least 30 seconds duration at a rate of 4 or more per 30 minutes- a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of 50 % or more - age: 18 years and above - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ever valinject gmbh - atosiban acetate 6,75 mg - eq. atosiban 6,75 mg - solution for injection - 6,75 mg/0,9 ml - atosiban acetate - atosiban

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ever valinject gmbh - atosiban acetate 37,5 mg - eq. atosiban 37,5 mg - concentrate for solution for infusion - 37,5 mg/5 ml - atosiban acetate - atosiban