SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| PRAVAFEN 40/160 mg | 160,40 mg,mg | Capsule, hard · Oral use | 30 Bottle | SAR 65.35 | NCE · Prescription | Laboratories SMB SA | Valid |
Indications — CHI Daman Drug Formulary
DYSLIPIDEMIA
EMA European Union — centrally authorised medicines
Pravafenix Laboratoires SMB S.A. · Authorised · authorised 14 Apr 2011 · ATC C10BA03
Therapeutic indication (EMA)
Pravafenix is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the treatment of mixed hyperlipidaemia in adult patients at high cardiovascular risk to reduce triglycerides and increase HDL C when LDL C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy or on another moderate-intensity statin regimen.
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.