Is Boceprevir approved by the US FDA?

Drugs@FDA lists 1 application product line for Boceprevir, including VICTRELIS (Discontinued).

Is Boceprevir authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Boceprevir.

Are there safety signals or safety updates for Boceprevir?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2017-01-30).

Active substance

Boceprevir

US FDA 1
EMA 1
Safety 4

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
VICTRELIS	200MG	capsule · oral	MERCK SHARP DOHME	Discontinued	13 May 2011

EMA European Union — centrally authorised medicines

Victrelis Merck Sharp Dohme Ltd · Withdrawn · authorised 18 Jul 2011 · ATC J05AE

Therapeutic indication (EMA)

Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

Safety signals and safety-related labeling changes

US FDA 30 Jan 2017 VICTRELIS — safety-related labeling change
Labeling sections changed: Contraindications
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 8 Oct 2015 PRAC signal: Hyponatraemia
Action for MAH: update of the product information: No
EMA PRAC 11 Jun 2015 PRAC signal: Hyponatraemia
Action for MAH: update of the product information: No

All safety entries for boceprevir →

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.