Regulatory PathRegulatory requirements compared

Active substance

Vernakalant

Open in the medicines table

EMA European Union — centrally authorised medicines

Brinavess Advanz Pharma Limited · Authorised · authorised 1 Sep 2010 · ATC C01BG11

Therapeutic indication (EMA)

Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: for non-surgery patients: atrial fibrillation </= 7 days duration; for post-cardiac surgery patients: atrial fibrillation </= 3 days duration.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BRINAVESS0246240020 MG / MLSOLUTION · INTRAVENOUSCIPHER PHARMACEUTICALS INC

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.