Brinavess

RSS

vernakalant hydrochloride

Authorised
This medicine is authorised for use in the European Union.

Overview

Brinavess is a medicine used to rapidly restore normal heart rhythm in adult patients who have recently started having atrial fibrillation. Atrial fibrillation happens when the atria (the upper chambers of the heart) contract irregularly and rapidly, resulting in abnormal heart rhythm. Brinavess is to be used for atrial fibrillation that has started within the last seven days, or within the last three days if the patient had recently had heart surgery.

Brinavess contains the active substance vernakalant hydrochloride.

This EPAR was last updated on 14/11/2019

Authorisation details

Product details
Name
Brinavess
Agency product number
EMEA/H/C/001215
Active substance
Vernakalant hydrochloride
International non-proprietary name (INN) or common name
vernakalant hydrochloride
Therapeutic area (MeSH)
Atrial Fibrillation
Anatomical therapeutic chemical (ATC) code
C01BG11
Publication details
Marketing-authorisation holder
Cardiome UK Limited
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
01/09/2010
Contact address

Lakeside House
1 Furzeground Way
Stockley Park
Uxbridge
Middlesex UB11 1BD
United Kingdom

Product information

19/09/2019 Brinavess - EMEA/H/C/001215 - II/0034

Contents

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Pharmacotherapeutic group

CARDIAC THERAPY

Therapeutic indication

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.

Assessment history

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