AZOPT Eye drops, suspension Ref.[6617] Active ingredients: Brinzolamide

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

AZOPT 10 mg/ml eye drops, suspension.

Pharmaceutical Form

Eye drops, suspension.

White to off-white suspension.

Qualitative and quantitative composition

Each ml of suspension contains 10 mg brinzolamide.

Excipient with known effect: Each ml of suspension contains 0.1 mg benzalkonium chloride.

For a full list of excipients, see section 6.1.

Active Ingredient Description

Brinzolamide is an inhibitor of carbonic anhydrase II (CA-II). Carbonic anhydrase (CA) is an enzyme found in many tissues of the body, including the eye. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humour secretion resulting in a reduction in intraocular pressure (IOP) which is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss.

List of Excipients

Benzalkonium chloride
Mannitol (E421)
Carbomer 974P
Edetate disodium
Sodium chloride
Hydrochloric acid/sodium hydroxide (to adjust pH)
Purified water

Pack sizes and marketing

5 and 10 ml opaque low density polyethylene bottles with polypropylene screw caps (droptainer).

The following pack sizes are available: outer cartons containing 1 × 5 ml, 3 × 5 ml and 1 × 10 ml bottles. Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers


Date of first authorisation: 9 March 2000
Date of latest renewal: 29 January 2010


Drug Countries
AZOPT Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Italy, Japan, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States

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