Is Telaprevir 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 Telaprevir.

Is Telaprevir approved by the US FDA?

Drugs@FDA lists 1 application product line for Telaprevir, including INCIVEK (Discontinued).

Is Telaprevir authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Telaprevir.

Are there safety signals or safety updates for Telaprevir?

EMA PRAC: 1 entry (latest 2016-06-09).

Active substance

Telaprevir

SFDA 1
US FDA 1
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
INCIVO 375MG FILM COATED TABLET	375 mg	Film-coated tablet · Oral use	42 Bottle	SAR 11611.55	NCE · Prescription	JANSSEN-CILAG	Withdrawn by MAH · Not Marketed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
INCIVEK	375MG	tablet · oral	VERTEX PHARMS	Discontinued	23 May 2011

EMA European Union — centrally authorised medicines

Incivo Janssen-Cilag International · Expired · authorised 19 Sep 2011 · ATC J05AE

Therapeutic indication (EMA)

Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): who are treatment naïve; who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.

Safety signals and safety-related labeling changes

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

All safety entries for telaprevir →

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.