Yellox

RSS

bromfenac

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

Overview

This is a summary of the European public assessment report (EPAR) for Yellox. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Yellox.

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

This EPAR was last updated on 16/06/2020

Authorisation details

Product details
Name
Yellox
Agency product number
EMEA/H/C/001198
Active substance
bromfenac sodium sesquihydrate
International non-proprietary name (INN) or common name
bromfenac
Therapeutic area (MeSH)
  • Pain, Postoperative
  • Ophthalmologic Surgical Procedures
Anatomical therapeutic chemical (ATC) code
S01BC11
Publication details
Marketing-authorisation holder
Bausch Health Ireland Limited
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
18/05/2011
Contact address

3013 Lake Drive
Citywest Business Campus
Dublin 24
D24PPT3 Ireland

Product information

14/03/2020 Yellox - EMEA/H/C/001198 - T/0024

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

Ophthalmologicals

Therapeutic indication

Treatment of postoperative ocular inflammation following cataract extraction in adults.

Assessment history

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