Atosiban SUN

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) 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.

This EPAR was last updated on 09/10/2019

Authorisation details

Product details
Name
Atosiban SUN
Agency product number
EMEA/H/C/002329
Active substance
atosiban acetate
International non-proprietary name (INN) or common name
atosiban
Therapeutic area (MeSH)
Premature Birth
Anatomical therapeutic chemical (ATC) code
G02CX01
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Sun Pharmaceutical Industries Europe B.V.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
31/07/2013
Contact address
Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Product information

30/08/2019 Atosiban SUN - EMEA/H/C/002329 - N/0016

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other gyneologicals

Therapeutic 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.

Assessment history

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