This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Tractocile : EPAR - Summary for the public (PDF/81.34 KB)
First published: 27/03/2009
Last updated: 22/01/2010
|Agency product number||
atosiban (as acetate)
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Ferring Pharmaceuticals A/S
|Date of issue of marketing authorisation valid throughout the European Union||
Amager Strandvej 405
30/03/2022 Tractocile - EMEA/H/C/000253 - IAIN/0077
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.