Simbrinza

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brinzolamide / brimonidine tartrate

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

Overview

This is a summary of the European public assessment report (EPAR) for Simbrinza. 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 Simbrinza.

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

This EPAR was last updated on 05/03/2019

Authorisation details

Product details
Name
Simbrinza
Agency product number
EMEA/H/C/003698
Active substance
  • brinzolamide
  • brimonidine tartrate
International non-proprietary name (INN) or common name
brinzolamide / brimonidine tartrate
Therapeutic area (MeSH)
  • Ocular Hypertension
  • Glaucoma, Open-Angle
Anatomical therapeutic chemical (ATC) code
S01EC54
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
18/07/2014
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

20/02/2019 Simbrinza - EMEA/H/C/003698 - R/0014

Contents

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

Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.

Assessment history

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