Israel - English - Ministry of Health

tzamal bio-pharma ltd - vernakalant hydrochloride - concentrate for solution for infusion - vernakalant hydrochloride 20 mg/ml - vernakalant - vernakalant - rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults who are hemodynamically stable.- for non-surgery patients: atrial fibrillation ≤ 7 days duration- for post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration

European Union - English - EMA (European Medicines Agency)

correvio - vernakalant hydrochloride - atrial fibrillation - cardiac therapy - rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults:for non-surgery patients: atrial fibrillation 

Canada - English - Health Canada

cipher pharmaceuticals inc - vernakalant hydrochloride - solution - 20mg - vernakalant hydrochloride 20mg - class iii antiarrythmics

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - vernakalant hydrochloride 20 mg/ml equivalent to 18.1 mg/ml of vernakalant - concentrate for infusion - 20 mg/ml - active: vernakalant hydrochloride 20 mg/ml equivalent to 18.1 mg/ml of vernakalant excipient: citric acid monohydrate sodium chloride sodium hydroxide water for injection - rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults · for non-surgery patients: atrial fibrillation less than or equal to 7 days duration · for post-cardiac surgery patients: atrial fibrillation less than or equal to 3 days duration

Singapore - English - HSA (Health Sciences Authority)

zuellig pharma pte. ltd. - vernakalant 18.1mg/ml equivalent vernakalant hydrochloride - infusion, solution concentrate - 20mg/ml

European Union - English - EMA (European Medicines Agency)

lupin europe gmbh - mexiletine hydrochloride - myotonic disorders - cardiac therapy - namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

pharmacare limited - infusion - each 1,0 ml solution contains vernakalant hydrochloride 20,0 mg

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

pharmacare limited - infusion - each 1,0 ml solution contains vernakalant hydrochloride 20,0 mg