Nexium Control

RSS

esomeprazole

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

Overview

This is a summary of the European public assessment report (EPAR) for Nexium Control. It explains how the European Medicines 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 Nexium Control.

For practical information about using Nexium Control, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 24/10/2018

Authorisation details

Product details
Name
Nexium Control
Agency product number
EMEA/H/C/002618
Active substance
esomeprazole
International non-proprietary name (INN) or common name
esomeprazole
Therapeutic area (MeSH)
Gastroesophageal Reflux
Anatomical therapeutic chemical (ATC) code
A02BC05
Publication details
Marketing-authorisation holder
Pfizer Healthcare Ireland
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
25/08/2013
Contact address

9 Riverwalk
National Digital Park
Citywest Business Campus
Dublin 24
D24 NT20

Product information

27/09/2018 Nexium Control - EMEA/H/C/002618 - T/0023

Contents

  • 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.

Pharmacotherapeutic group

Proton pump inhibitors

Therapeutic indication

Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.

Assessment history

How useful was this page?

Add your rating