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.
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.
Therapeutic Area (MeSH)
ATC Code
G02CX01
ATC Item
atosiban
Pharmacotherapeutic Group
Other gynecologicals
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| atosiban (as acetate) | N/A | atosiban (as acetate) |
EMA Name
Atosiban SUN
Medicine Name
Atosiban SUN
Aliases
N/ANo risk management plan link.
