Regulatory PathRegulatory requirements compared

Active substance

Atosiban

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
PREMABAN7.5 mg/mlSolution for injection · Intravenous use1 VialSAR 45.05Generic · PrescriptionEVER Valinject GmbHValid
PREMABAN7.5 mg/mlSolution for injection · Intravenous use1 VialSAR 250.35Generic · PrescriptionEVER Valinject GmbHValid
TRACTOCILE concentrate for solution for infusion7.5 mg/mlSolution for injection · Intravenous use1 VialSAR 335.00NCE · PrescriptionFERRING INTERNATIONAL CENTER SAValid
TRACTOCILE solution for injection7.5 mg/mlSolution for injection · Intravenous use1 VialSAR 87.60NCE · PrescriptionFERRING INTERNATIONAL CENTER SAValid

EMA European Union — centrally authorised medicines

Tractocile Ferring Pharmaceuticals A/S · Authorised · authorised 20 Jan 2000 · ATC G02CX01

Therapeutic indication (EMA)

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.

Atosiban SUN Sun Pharmaceutical Industries Europe B.V. · Authorised · authorised 31 Jul 2013 · ATC G02CX01

Therapeutic indication (EMA)

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.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.