Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 06 September 2018

Indication(s)

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

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/002329
Orphan designation No
Date First Approved 31-07-2013
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Sun Pharmaceutical Industries Europe B.V.