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AZOPT Eye drops, suspension (2018)

Active ingredients: Brinzolamide

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.

Chemical substance
Description
Brinzolamide

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
Tyloxapol
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
Authorization dates

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

Date of first authorisation: 9 March 2000

Date of latest renewal: 29 January 2010

Marketing authorization number:

EU/1/00/129/001-3