Is Brinzolamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Brinzolamide, including AZOPT 1% (1 %, Eye drops, suspension, SAR 29.20).

Is Brinzolamide approved by the US FDA?

Drugs@FDA lists 4 application product lines for Brinzolamide, including AZOPT (Prescription); BRINZOLAMIDE (Prescription); BRINZOLAMIDE (Prescription); BRINZOLAMIDE (Discontinued).

Is Brinzolamide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Brinzolamide: Azopt.

Are there safety signals or safety updates for Brinzolamide?

US FDA: 2 entries (latest 2023-06-28).

Active substance

Brinzolamide

SFDA 1
US FDA 4
EMA 1
Health Canada 1
US price lines 4
NHS prices 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AZOPT 1%	1 %	Eye drops, suspension · Ocular use	1 Dropper Container	SAR 29.20	NCE · Prescription	NOVARTIS PHARMA AG	Valid

Indications — CHI Daman Drug Formulary

NON-INFECTIOUS UVEITIS; OPEN ANGLE GLUCOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
AZOPT	1%	suspension/drops · ophthalmic	SANDOZ	Prescription	1 Apr 1998
BRINZOLAMIDE	1%	suspension/drops · ophthalmic	WATSON LABS INC	Prescription	27 Nov 2020
BRINZOLAMIDE	1%	suspension/drops · ophthalmic	BAUSCH AND LOMB	Prescription	18 Aug 2021
BRINZOLAMIDE	1%	suspension/drops · ophthalmic	PADAGIS US	Discontinued	28 Jul 2023

EMA European Union — centrally authorised medicines

Azopt Novartis Europharm Limited · Authorised · authorised 9 Mar 2000 · ATC S01EC04

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AZOPT	02238873	1 % / W/V	SUSPENSION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AZOPT 1% EYE DROPS	$35.06272	per ML	23 Sep 2026
US NADAC	AZOPT 1% EYE DROPS	$35.29803	per ML	23 Sep 2026
US NADAC	BRINZOLAMIDE 1% EYE DROPS	$8.52641	per ML	23 Sep 2026
US NADAC	BRINZOLAMIDE 1% EYE DROPS	$9.474	per ML	23 Sep 2026
NHS Drug Tariff	Brinzolamide 10mg/ml eye drops	£2.11	5 ml	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 28 Jun 2023 AZOPT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 May 2023 SIMBRINZA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for brinzolamide →

Combinations containing Brinzolamide

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.