Basic Information
Atosiban SUN
Regulatory Information
EMEA/H/C/002329
July 31, 2013
10
June 19, 2024
Company Information
the netherlands
Polarisavenue 87 2132JH Hoofddorp
Sun Pharmaceutical Industries (Europe) B.V.
Drug Classification
Active Substances Detail
atosiban (as acetate)
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Atosiban SUN. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Atosiban SUN. For practical information about using Atosiban SUN, patients should read the package leaflet or contact their doctor or pharmacist.