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 19/12/2022

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
10
Date of issue of marketing authorisation valid throughout the European Union
18/07/2014
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

10/12/2022 Simbrinza - EMEA/H/C/003698 - IB/0024/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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