Cancellation of state registration. Amiodarone Sandoz®

November 27, 2017

Active substances:

Amiodarone

Trade names:

Amiodarone Sandoz®

ICD-10:

IX.I30-I52.I45.6 Syndrome of premature agitation

IX.I30-I52.I47.1 Nadzheludochkovaya tachycardia

IX.I30-I52.I47.2 Ventricular tachycardia

IX.I30-I52.I48 Atrial fibrillation and flutter

IX.I30-I52.I49.0 Fibrillation and flutter of the ventricles

IX.I30-I52.I49.4 Other and unspecified depolarization

Amiodarone, antiarrhythmic drug, arrhythmia treatment, ventricular fibrillation, atrial fibrillation, ventricular flutter, atrial flutter, extrasystole, tachycardia

The Ministry of Health of the Russian Federation in accordance with Article 32 of the Federal Law of 12.04.2010 No. 61-FZ "On the circulation of medicines" decided to abolish state registration and exclude from the state register of medicines for medical use of the medicinal product (registration certificate LP-000770 dated 29.09.2011 issued by Sandoz dd, Slovenia):

Amiodarone Sandoz® (trade name of the medicinal product)

Amiodarone (international non-proprietary or grouping or chemical name)

tablets, 200 mg (dosage form, dosage)

Salutas Pharma GmbH, Germany Otto-von-Guericke-Allee 1, 39179 Barleben, Cermany (name and address of the location of the manufacturer of the medicinal product)

on the basis of filing an application by an authorized legal entity of ZAO Sandoz to cancel the state registration of the medicinal product.