Is Fenofibrate + Simvastatin 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 Fenofibrate + Simvastatin, including Cholib 145/20 (145,20 mg,mg, Film-coated tablet, SAR 60.40); Cholib 145/40 (145,40 mg,mg, Film-coated tablet, SAR 64.85).

Is Fenofibrate + Simvastatin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Fenofibrate + Simvastatin: Cholib.

Active substances

Fenofibrate + Simvastatin

SFDA 2
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Cholib 145/20	145,20 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 60.40	NCE · Prescription	Abbott Laboratories Limited	Valid
Cholib 145/40	145,40 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 64.85	NCE · Prescription	Abbott Laboratories Limited	Valid

Indications — CHI Daman Drug Formulary

DYSLIPIDEMIA

EMA European Union — centrally authorised medicines

Cholib Viatris Healthcare Limited · Authorised · authorised 26 Aug 2013 · ATC C10BA04

Therapeutic indication (EMA)

Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL C levels when LDL C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.

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.