Azopt

RSS

brinzolamide

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

Overview

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

This EPAR was last updated on 17/11/2021

Authorisation details

Product details
Name
Azopt
Agency product number
EMEA/H/C/000267
Active substance
brinzolamide
International non-proprietary name (INN) or common name
brinzolamide
Therapeutic area (MeSH)
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Anatomical therapeutic chemical (ATC) code
S01EC04
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
09/03/2000
Contact address

Elm Park
Merrion Road
Dublin 4 
Ireland

Product information

12/10/2021 Azopt - EMEA/H/C/000267 - IAIN/0074/G

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

Azopt is indicated to decrease elevated intraocular pressure in:

  • ocular hypertension;
  • open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.

Assessment history

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