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 17/11/2021

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
15
Date of issue of marketing authorisation valid throughout the European Union
25/11/2008
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

28/10/2021 Azarga - EMEA/H/C/000960 - II/0045

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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

Assessment history

How useful was this page?

Add your rating
Average
1 rating
2 ratings