Is Lomefloxacin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Lomefloxacin, including LOMAX 400MG TAB (400 mg, Film-coated tablet, SAR 61.05).

Is Lomefloxacin approved by the US FDA?

Drugs@FDA lists 1 application product line for Lomefloxacin, including MAXAQUIN (Discontinued).

Are there safety signals or safety updates for Lomefloxacin?

EMA PRAC: 5 entries (latest 2021-09-02).

Active substance

Lomefloxacin

SFDA 3
US FDA 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LOMAX 400MG TAB	400 mg	Film-coated tablet · Oral use	10 Blister	SAR 61.05	NCE · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
LOMAX 400MG TAB	400 mg	Film-coated tablet · Oral use	5 Blister	SAR 34.20	NCE · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
OKACIN 0.3% EYE DROPS	0.3 %	Eye drops · Ocular use	1 Dropper Container	SAR 17.70	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

TRAVEL RELATED INFECTIONS-TREATMENT

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

Product	Strength	Form · route	Applicant	Status	First approved
MAXAQUIN	EQ 400MG BASE	tablet · oral	PHARMACIA	Discontinued	21 Feb 1992

Safety signals and safety-related labeling changes

EMA PRAC 2 Sep 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No
EMA PRAC 9 Apr 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No
EMA PRAC 3 Sep 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: Yes
EMA PRAC 14 May 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: No
EMA PRAC 16 Jan 2020 PRAC signal: Heart valve regurgitation
Action for MAH: update of the product information: No

All safety entries for lomefloxacin →

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.