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Atosiban

Also known as: Tractocile · Atosiban SUN

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In short

In the European Union, Atosiban is indicated to delay imminent pre-term birth in pregnant adult women. This indication applies when there are regular uterine contractions of at least 30 seconds duration at a rate of 4 or more per 30 minutes. It also requires a cervical dilation of 1 to 3 cm (0 to 3 for nulliparas), an effacement of 50% or more, a gestational age from 24 until 33 completed weeks, and a normal foetal heart rate.

Source: European Medicines Agency (EMA), Tractocile — EPAR, 30/03/2022. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
59639 atosiban
EMA
EMEA/H/C/000253, EMEA/H/C/002329

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Tractocile

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.

Source: European Medicines Agency (EMA), Tractocile — EPAR, 30/03/2022. © European Medicines Agency.

Document date: 30/03/2022 · Official document →

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Questions

What is Atosiban approved for in the European Union?

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. (Source: European Medicines Agency (EMA), Tractocile — EPAR, 30/03/2022. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Tractocile — EPAR, 30/03/2022. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →