This is a summary of the European public assessment report (EPAR) for Atosiban SUN. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Atosiban SUN.
For practical information about using Atosiban SUN, patients should read the package leaflet or contact their doctor or pharmacist.
Atosiban SUN : EPAR - Summary for the public (PDF/77.27 KB)
First published: 07/08/2013
Last updated: 07/08/2013
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Sun Pharmaceutical Industries Europe B.V.
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30/08/2019 Atosiban SUN - EMEA/H/C/002329 - N/0016
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.