brinzolamide / timolol
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.
Azarga : EPAR - Summary for the public (PDF/79.47 KB)
First published: 16/01/2009
Last updated: 27/05/2014
Azarga : EPAR - Risk management plan summary (PDF/49.57 KB)
First published: 17/11/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
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.
Decrease of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.