Tractocile

RSS

atosiban

Authorised
This medicine is authorised for use in the European Union.

Overview

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).

This EPAR was last updated on 30/03/2022

Authorisation details

Product details
Name
Tractocile
Agency product number
EMEA/H/C/000253
Active substance
atosiban (as acetate)
International non-proprietary name (INN) or common name
atosiban
Therapeutic area (MeSH)
Premature Birth
Anatomical therapeutic chemical (ATC) code
G02CX01
Publication details
Marketing-authorisation holder
Ferring Pharmaceuticals A/S
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
20/01/2000
Contact address

Amager Strandvej 405
2770 Kastrup
Denmark

Product information

30/03/2022 Tractocile - EMEA/H/C/000253 - IAIN/0077

Product information documents contain:

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.

Pharmacotherapeutic group

Other gynecologicals

Therapeutic indication

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.

Assessment history

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