Is Latanoprost registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Latanoprost, including LATANO 0.005% W-V OPHTHALMIC SOLUTION (0.05 mg/ml, Eye drops, solution, SAR 40.50); Ocuotan (0.05 mg, Eye drops, solution, SAR 38.40); XALATAN 50MCG\ML EYE DROP (0.05 mg/ml, Eye drops, solution, SAR 42.65).

Is Latanoprost approved by the US FDA?

Drugs@FDA lists 15 application product lines for Latanoprost, including XALATAN (Prescription); LATANOPROST (Prescription); LATANOPROST (Prescription); LATANOPROST (Prescription); LATANOPROST (Prescription).

Is Latanoprost authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Latanoprost: Catiolanze.

Is Latanoprost on the WHO Model List of Essential Medicines?

Yes — 21.4. Ophthalmological preparations > Miotics and antiglaucoma medicines (core list): Primary open-angle glaucoma.

Are there safety signals or safety updates for Latanoprost?

EMA PRAC: 4 entries; US FDA: 4 entries; MHRA: 1 entry (latest 2025-01-24).

Active substance

Latanoprost

SFDA 4
US FDA 15
EMA 1
Health Canada 10
US price lines 4
NHS prices 4
WHO EML 1
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LATANO 0.005% W-V OPHTHALMIC SOLUTION	0.05 mg/ml	Eye drops, solution · Ophthalmic use	1 Dropper Container	SAR 40.50	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Ocuotan	0.05 mg	Eye drops, solution · Ophthalmic use	1 Bottle	SAR 38.40	Generic · Prescription	Advanced Pharmaceutical Industries	Valid
XALATAN 50MCG\ML EYE DROP	0.05 mg/ml	Eye drops, solution · Ophthalmic use	1 Dropper Container	SAR 42.65	NCE · Prescription	Upjohn SRL	Valid
LATAPROST 0.005% EYE DROPS	50 µ/ml	Eye drops, solution · Ophthalmic use	1 Bottle	SAR 32.60	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed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
XALATAN	0.005%	solution/drops · ophthalmic	UPJOHN	Prescription	5 Jun 1996
LATANOPROST	0.005%	solution/drops · ophthalmic	SANDOZ	Prescription	22 Mar 2011
LATANOPROST	0.005%	solution/drops · ophthalmic	J MOLNER	Prescription	22 Mar 2011
LATANOPROST	0.005%	solution/drops · ophthalmic	BAUSCH AND LOMB	Prescription	22 Mar 2011
LATANOPROST	0.005%	solution/drops · ophthalmic	SOMERSET	Prescription	22 Mar 2011
LATANOPROST	0.005%	solution/drops · ophthalmic	FDC LTD	Prescription	22 Apr 2016
IYUZEH	0.005%	solution/drops · ophthalmic	THEA PHARMA	Prescription	13 Dec 2022
LATANOPROST	0.005%	solution/drops · ophthalmic	GLAND	Prescription	26 Nov 2024
LATANOPROST	0.005%	solution/drops · ophthalmic	MICRO LABS	Prescription	14 Apr 2025
LATANOPROST	0.005%	solution/drops · ophthalmic	APOTEX INC	Discontinued	22 Mar 2011
LATANOPROST	0.005%	solution/drops · ophthalmic	EPIC PHARMA LLC	Discontinued	19 Jul 2011
LATANOPROST	0.005%	solution/drops · ophthalmic	CARNEGIE	Discontinued	11 Feb 2013
XELPROS	0.005%	emulsion · ophthalmic	SUN PHARM	Discontinued	12 Sep 2018
LATANOPROST	0.005%	solution/drops · ophthalmic	EUGIA PHARMA	Discontinued	3 Sep 2019
LATANOPROST	0.005%	solution/drops · ophthalmic	MANKIND PHARMA	Discontinued	17 Dec 2025

EMA European Union — centrally authorised medicines

Catiolanze Santen Oy · Authorised · authorised 15 Nov 2023 · ATC S01EE01

Therapeutic indication (EMA)

Catiolanze is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension. Catiolanze is indicated for the reduction of elevated IOP in children from 4 years of age and adolescents with elevated IOP and paediatric glaucoma.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AG-LATANOPROST	02534835	50 MCG / ML	SOLUTION · OPHTHALMIC	ANGITA PHARMA INC.
APO-LATANOPROST	02296527	50 MCG / ML	SOLUTION · OPHTHALMIC	APOTEX INC
JAMP LATANOPROST	02453355	50 MCG / ML	SOLUTION · OPHTHALMIC	JAMP PHARMA CORPORATION
M-LATANOPROST	02513285	50 MCG / ML	SOLUTION · OPHTHALMIC	MANTRA PHARMA INC
MED-LATANOPROST	02426935	50 MCG / ML	SOLUTION · OPHTHALMIC	GENERIC MEDICAL PARTNERS INC
MONOPROST	02456230	50 MCG / ML	SOLUTION · OPHTHALMIC	LABORATOIRES THEA
MYLAN-LATANOPROST	02373041	50 MCG / ML	SOLUTION · OPHTHALMIC	MYLAN PHARMACEUTICALS ULC
RIVA-LATANOPROST	02341085	50 MCG / ML	SOLUTION · OPHTHALMIC	LABORATOIRE RIVA INC.
SANDOZ LATANOPROST	02367335	50 MCG / ML	SOLUTION · OPHTHALMIC	SANDOZ CANADA INCORPORATED
XALATAN	02231493	50 MCG / ML	SOLUTION · OPHTHALMIC	BGP PHARMA ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	IYUZEH 0.005% EYE DROP	$10.12265	per EA	23 Sep 2026
US NADAC	LATANOPROST 0.005% EYE DROPS	$1.57513	per ML	23 Sep 2026
US NADAC	LATANOPROST 0.005% EYE DROPS	$1.23775	per ML	23 Sep 2026
US NADAC	XALATAN 0.005% EYE DROPS	$108.34219	per ML	23 Sep 2026
NHS Drug Tariff	Latanoprost 50micrograms/ml eye drops	£1.90	2.5 ml	1 Oct 2026
NHS Drug Tariff	Latanoprost 50micrograms/ml eye drops 0.2ml unit dose preservative free	£8.49	30 unit dose	1 Oct 2026
NHS Drug Tariff	Latanoprost 50micrograms/ml eye drops 0.2ml unit dose preservative free	£25.47	90 unit dose	1 Oct 2026
NHS Drug Tariff	Latanoprost 50micrograms/ml eye drops preservative free	£7.99	2.5 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.

WHO WHO Model List of Essential Medicines (2025)

21.4. Ophthalmological preparations > Miotics and antiglaucoma medicines · core
Primary open-angle glaucoma
Local > Ophthalmological > Solution (eye drops): 50 µg per mL eye drops

Safety signals and safety-related labeling changes

US FDA 24 Jan 2025 ROCKLATAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 9 Oct 2024 XELPROS — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 16 Sep 2024 IYUZEH — safety-related labeling change
Labeling sections changed: Adverse Reactions
EMA PRAC 12 May 2023 PRAC signal: Choroidal detachment and choroidal effusion
Action for MAH: update of the product information: No
US FDA 19 Dec 2022 XALATAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 20 Jul 2015 Latanoprost (Xalatan): increased reporting of eye irritation since reformulation
Advise patients to tell their health professional if they experience severe eye irritation.
EMA PRAC 7 May 2015 PRAC signal: Increased reporting of eye disorders, in particular eye irritation, after change of formulation
Action for MAH: update of the product information: Yes
EMA PRAC 9 Jan 2015 PRAC signal: Increased reporting of eye disorders, in particular eye irritation, after change of formulation
Action for MAH: update of the product information: No
EMA PRAC 11 Sep 2014 PRAC signal: Increased reporting of eye disorders, in particular eye irritation, after change of formulation
Action for MAH: update of the product information: No

All safety entries for latanoprost →

Combinations containing Latanoprost

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.