Is Ezetimibe + Rosuvastatin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Ezetimibe + Rosuvastatin, including LIPOCOMB (10,10 mg,mg, Capsule, hard, SAR 80.45); LIPOCOMB (20,10 mg,mg, Capsule, hard, SAR 97.65); Roneza (5,10 mg,mg, Film-coated tablet, SAR 184.10); Roneza (10,10 mg,mg, Film-coated tablet, SAR 221.95); Roneza (20,10 mg,mg, Film-coated tablet, SAR 274.60).

Is Ezetimibe + Rosuvastatin approved by the US FDA?

Drugs@FDA lists 1 application product line for Ezetimibe + Rosuvastatin, including ROSZET (Discontinued).

Active substances

Ezetimibe + Rosuvastatin

SFDA 9
US FDA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LIPOCOMB	10,10 mg,mg	Capsule, hard · Oral use	30 Blister	SAR 80.45	NCE · Prescription	LES LABORATOIRES SERVIER	Valid
LIPOCOMB	20,10 mg,mg	Capsule, hard · Oral use	30 Blister	SAR 97.65	NCE · Prescription	LES LABORATOIRES SERVIER	Valid
Roneza	5,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 184.10	NCE · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Roneza	10,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 221.95	NCE · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Roneza	20,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 274.60	NCE · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Roneza	40,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 356.70	NCE · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Zympass	10,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 80.45	NCE · Prescription	Sanofi-aventis Ireland Limited	Valid
Zympass	20,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 97.65	NCE · Prescription	Sanofi-aventis Ireland Limited	Valid
Zympass	40,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 101.25	NCE · Prescription	Sanofi-aventis Ireland Limited	Valid

Indications — CHI Daman Drug Formulary

CORONARY ARTERY DISEASE; DYSLIPIDEMIA

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

Product	Strength	Form · route	Applicant	Status	First approved
ROSZET	10MG;EQ 5MG BASE; 10MG;EQ 10MG BASE; 10MG;EQ 20MG BASE; 10MG;EQ 40MG BASE	tablet · oral	ALTHERA PHARMS	Discontinued	23 Mar 2021

Components

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.