Is Vismodegib approved by the US FDA?

Drugs@FDA lists 1 application product line for Vismodegib, including ERIVEDGE (Prescription).

Is Vismodegib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vismodegib: Erivedge.

Are there safety signals or safety updates for Vismodegib?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2023-03-27).

Active substance

Vismodegib

US FDA 1
EMA 1
Health Canada 1
Safety 4

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ERIVEDGE	150MG	capsule · oral	GENENTECH	Prescription	30 Jan 2012

EMA European Union — centrally authorised medicines

Erivedge Roche Registration GmbH · Authorised · authorised 12 Jul 2013 · ATC L01XX43

Therapeutic indication (EMA)

Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ERIVEDGE	02409267	150 MG	CAPSULE · ORAL	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 27 Mar 2023 ERIVEDGE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 13 Feb 2020 PRAC signal: Pancreatitis
Action for MAH: update of the product information: No
EMA PRAC 3 Oct 2019 PRAC signal: Pancreatitis
Action for MAH: update of the product information: No
EMA PRAC 3 Dec 2015 PRAC signal: Angioedema
Action for MAH: update of the product information: No

All safety entries for vismodegib →

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.