Azarga

RSS

brinzolamide / timolol

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

Overview

This is a summary of the European public assessment report (EPAR) for Azarga. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Azarga.

This EPAR was last updated on 11/07/2018

Authorisation details

Product details
Name
Azarga
Agency product number
EMEA/H/C/000960
Active substance
  • brinzolamide
  • timolol maleate
International non-proprietary name (INN) or common name
brinzolamide / timolol
Therapeutic area (MeSH)
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Anatomical therapeutic chemical (ATC) code
S01ED51
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
25/11/2008
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

22/06/2018 Azarga - EMEA/H/C/000960 - IA/0040

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

Decrease of 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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