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🇪🇺EU · EMAAuthorisedATC: G02CX01

Atosiban SUN(atosiban (as acetate))

Obstetric Labor, Premature

Marketing Authorisation Holder: Sun Pharmaceutical Industries Europe B.V.

EMA Authorisation: 31/07/2013

INN: atosiban

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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.