Is Simeprevir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Simeprevir.

Is Simeprevir approved by the US FDA?

Drugs@FDA lists 1 application product line for Simeprevir, including OLYSIO (Discontinued).

Is Simeprevir authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Simeprevir.

Are there safety signals or safety updates for Simeprevir?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2017-11-09).

Active substance

Simeprevir

SFDA 1
US FDA 1
EMA 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OLYSIO 150MG Capsule	150 mg	Capsule · Oral use	7 Blister	SAR 11775.05	NCE · Prescription	JANSSEN-CILAG	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
OLYSIO	EQ 150MG BASE	capsule · oral	JANSSEN PRODS	Discontinued	22 Nov 2013

EMA European Union — centrally authorised medicines

Olysio Janssen-Cilag International NV · Withdrawn · authorised 14 May 2014 · ATC J05AE14

Therapeutic indication (EMA)

Olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. For hepatitis C virus (HCV) genotype specific activity.

Safety signals and safety-related labeling changes

US FDA 9 Nov 2017 OLYSIO — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 2 Sep 2016 PRAC signal: Drug interaction between direct-acting antivirals (DAAV) and vitamin K antagonists leading to a reduced international normalized ratio (INR)
Action for MAH: update of the product information: Yes
EMA PRAC 9 Jun 2016 PRAC signal: Drug interaction with fluindione leading to a reduced international normalized ratio (INR)
Action for MAH: update of the product information: No
EMA PRAC 14 Apr 2016 PRAC signal: Unexpected early hepatocellular carcinoma recurrence
Action for MAH: update of the product information: No

All safety entries for simeprevir →

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.