Is Brimonidine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Brimonidine, including ALPHAGAN-P 0.15% OPHTHALMIC SOLUTION (0.15 %, Ophthalmic solution, SAR 26.95); BRIMO (0.2 %, Eye drops, SAR 38.50); BRIMO-P OPHTHALMIC SOLUTION 0.1% (0.1 %, Eye drops, solution, SAR 25.65); Brimo-P (1.5 mg/ml, Eye drops, solution, SAR 34.65); Lumify (0.25 mg/ml, Eye drops, solution, SAR 38.50).

Is Brimonidine approved by the US FDA?

Drugs@FDA lists 30 application product lines for Brimonidine, including ALPHAGAN P (Prescription); BRIMONIDINE TARTRATE (Prescription); BRIMONIDINE TARTRATE (Prescription); ALPHAGAN P (Prescription); BRIMONIDINE TARTRATE (Prescription).

Is Brimonidine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Brimonidine: Mirvaso.

Are there safety signals or safety updates for Brimonidine?

US FDA: 8 entries (latest 2026-03-17).

Active substance

Brimonidine

SFDA 10
US FDA 30
EMA 1
Health Canada 10
US price lines 19
NHS prices 2
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALPHAGAN-P 0.15% OPHTHALMIC SOLUTION	0.15 %	Ophthalmic solution · Ophthalmic use	1 Dropper Container	SAR 26.95	NCE · Prescription	AbbVie Inc	Valid
BRIMO	0.2 %	Eye drops · Ophthalmic use	1 Bottle	SAR 38.50	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
BRIMO-P OPHTHALMIC SOLUTION 0.1%	0.1 %	Eye drops, solution · Ophthalmic use	1 Dropper Container	SAR 25.65	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Brimo-P	1.5 mg/ml	Eye drops, solution · Ophthalmic use	1 Bottle	SAR 34.65	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Lumify	0.25 mg/ml	Eye drops, solution · Ophthalmic use	10 Multidose container	SAR 38.50	NCE · OTC	Bausch & Lomb, Incorporated	Valid
MIRVASO 3 MG/G GEL	3 mg/g	Gel · Topical	30 Tube	SAR 186.75	NCE · Prescription	GALDERMA	Valid
OCUDINE 0.15% EYE DROPS SOLUTION	0.15 %	Ophthalmic solution · Ophthalmic use	20 Dropper Container	SAR 34.45	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
OCUDINE 0.2% OPHTHALMIC SOLUTION	2 mg/ml	Ophthalmic solution · Ophthalmic use	20 Ampoule	SAR 45.95	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
BRIMODIN	0.2 %	Eye drops · Ophthalmic use	1 Bottle	SAR 31.90	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
MIRVASO 3 MG/G GEL	3 mg/g	Gel · Topical	10 Tube	SAR 62.25	NCE · Prescription	GALDERMA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

OPEN ANGLE GLUCOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
ALPHAGAN P	0.15%	solution/drops · ophthalmic	ABBVIE	Prescription	16 Mar 2001
BRIMONIDINE TARTRATE	0.2%	solution/drops · ophthalmic	BAUSCH AND LOMB INC	Prescription	28 May 2003
BRIMONIDINE TARTRATE	0.2%	solution/drops · ophthalmic	SANDOZ	Prescription	16 Sep 2003
ALPHAGAN P	0.1%	solution/drops · ophthalmic	ABBVIE	Prescription	19 Aug 2005
BRIMONIDINE TARTRATE	0.2%	solution/drops · ophthalmic	RISING	Prescription	14 Mar 2006
QOLIANA	0.15%	solution/drops · ophthalmic	SANDOZ	Prescription	22 May 2006
BRIMONIDINE TARTRATE	0.2%	solution/drops · ophthalmic	SANDOZ	Prescription	30 Jan 2008
MIRVASO	EQ 0.33% BASE	gel · topical	GALDERMA LABS LP	Prescription	23 Aug 2013
BRIMONIDINE TARTRATE	0.2%	solution/drops · ophthalmic	REGCON HOLDINGS	Prescription	18 Nov 2014
LUMIFY	0.025%	solution/drops · ophthalmic	BAUSCH AND LOMB INC	Over-the-counter	22 Dec 2017
BRIMONIDINE TARTRATE	0.2%	solution/drops · ophthalmic	SOMERSET THERAPS LLC	Prescription	11 Mar 2019
BRIMONIDINE TARTRATE	EQ 0.33% BASE	gel · topical	PADAGIS ISRAEL	Prescription	23 Sep 2021
BRIMONIDINE TARTRATE	0.15%	solution/drops · ophthalmic	APOTEX	Prescription	31 Jan 2022
BRIMONIDINE TARTRATE	0.1%	solution/drops · ophthalmic	APOTEX	Prescription	21 Dec 2022
BRIMONIDINE TARTRATE	0.15%	solution/drops · ophthalmic	ALEMBIC	Prescription	29 Mar 2023
BRIMONIDINE TARTRATE	0.1%	solution/drops · ophthalmic	ALEMBIC	Prescription	1 Aug 2023
BRIMONIDINE TARTRATE	0.2%	solution/drops · ophthalmic	MICRO LABS	Prescription	22 Nov 2023
BRIMONIDINE TARTRATE	0.025%	solution/drops · ophthalmic	DR REDDYS LABS SA	Over-the-counter	16 Feb 2024
BRIMONIDINE TARTRATE	0.1%	solution/drops · ophthalmic	SANDOZ	Prescription	4 Mar 2024
LUMIFY PRESERVATIVE FREE	0.025%	solution/drops · ophthalmic	BAUSCH AND LOMB INC	Over-the-counter	19 Apr 2024
BRIMONIDINE TARTRATE	0.15%	solution/drops · ophthalmic	UPSHER SMITH LABS	Prescription	12 Jun 2024
BRIMONIDINE TARTRATE	0.1%	solution/drops · ophthalmic	SOMERSET THERAPS LLC	Prescription	9 Aug 2024
BRIMONIDINE TARTRATE	0.1%	solution/drops · ophthalmic	LUPIN	Prescription	26 Aug 2024
BRIMONIDINE TARTRATE	0.1%	solution/drops · ophthalmic	UPSHER SMITH LABS	Prescription	30 Jul 2025
BRIMONIDINE TARTRATE	0.1%	solution/drops · ophthalmic	GLAND	Prescription	11 Mar 2026

5 more — full table

EMA European Union — centrally authorised medicines

Mirvaso Galderma International · Authorised · authorised 20 Feb 2014 · ATC D11AX21

Therapeutic indication (EMA)

Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALPHAGAN	02236876	0.2 % / W/V	SOLUTION · OPHTHALMIC	ABBVIE CORPORATION
ALPHAGAN P	02248151	0.15 % / W/V	SOLUTION · OPHTHALMIC	ABBVIE CORPORATION
BRIMONIDINE	02562316	0.2 % / W/V	SOLUTION · OPHTHALMIC	STERI-MED PHARMA INC.
BRIMONIDINE P	02301334	0.15 % / W/V	SOLUTION · OPHTHALMIC	AA PHARMA INC
JAMP BRIMONIDINE	02449226	0.2 % / W/V	SOLUTION · OPHTHALMIC	JAMP PHARMA CORPORATION
LUMIFY	02517698	0.025 % / W/V	SOLUTION · OPHTHALMIC	BAUSCH & LOMB INC
MED-BRIMONIDINE	02507811	0.2 % / W/V	SOLUTION · OPHTHALMIC	GENERIC MEDICAL PARTNERS INC
ONRELTEA	02421208	0.33 % / W/W	GEL · TOPICAL	GALDERMA CANADA INC.
RIVA-BRIMONIDINE	02515350	0.2 % / W/V	SOLUTION · OPHTHALMIC	LABORATOIRE RIVA INC.
SANDOZ BRIMONIDINE	02305429	0.2 %	SOLUTION · OPHTHALMIC	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ALPHAGAN P 0.1% DROPS	$37.35499	per ML	23 Sep 2026
US NADAC	ALPHAGAN P 0.1% DROPS	$37.26824	per ML	23 Sep 2026
US NADAC	ALPHAGAN P 0.1% DROPS	$37.25406	per ML	23 Sep 2026
US NADAC	ALPHAGAN P 0.15% EYE DROPS	$39.74875	per ML	23 Sep 2026
US NADAC	ALPHAGAN P 0.15% EYE DROPS	$39.80818	per ML	23 Sep 2026
US NADAC	ALPHAGAN P 0.15% EYE DROPS	$39.84933	per ML	23 Sep 2026
US NADAC	BRIMONIDINE 0.2% EYE DROP	$0.85299	per ML	30 Sep 2026
US NADAC	BRIMONIDINE 0.2% EYE DROP	$0.57862	per ML	23 Sep 2026
US NADAC	BRIMONIDINE 0.2% EYE DROP	$0.50116	per ML	23 Sep 2026
US NADAC	BRIMONIDINE 0.33% GEL PUMP	$13.92613	per GM	23 Sep 2026
US NADAC	BRIMONIDINE TARTRATE 0.1% DROP	$10.51982	per ML	23 Sep 2026
US NADAC	BRIMONIDINE TARTRATE 0.1% DROP	$9.05936	per ML	23 Sep 2026
NHS Drug Tariff	Brimonidine 0.2% eye drops	£1.79	5 ml	1 Oct 2026
NHS Drug Tariff	Brimonidine 3mg/g gel	£33.69	30 gram	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 17 Mar 2026 COMBIGAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 21 Nov 2025 QOLIANA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Sep 2025 ALPHAGAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 18 Sep 2025 ALPHAGAN P — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 18 Sep 2025 ALPHAGAN P — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
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
US FDA 21 Feb 2019 LUMIFY — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 27 Jul 2016 MIRVASO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for brimonidine →

Combinations containing Brimonidine

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.