Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Brinavess   
Auth. number : EU/1/10/645
INN : vernakalant hydrochloride
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C01 - Cardiac therapy
Pharmacological subgroup: C01B - Antiarrhythmics, class I and III
Chemical subgroup: C01BG - Other class I antiarrhythmics
Chemical substance: C01BG11 - Vernakalant
(See WHO ATC Index)
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
Marketing Authorisation Holder: Cardiome UK Limited
Sherborne House, 119-121 Cannon Street, 3rd Floor, London EC4N 5AT, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
03/09/2010 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1215 (2010)6130 of 01/09/2010
06/09/2010 Centralised - Authorisation EMEA/H/C/1215 (2010)6128 of 01/09/2010
30/09/2010 Centralised - Variation EMEA/H/C/1215/N/1
Updated with Decision(2011)972 of 11/02/2011
18/11/2010 Centralised - Variation EMEA/H/C/1215/IG/27/G
Updated with Decision(2011)972 of 11/02/2011
15/02/2011 Centralised - Variation (2011)972 of 11/02/2011
15/04/2011 Centralised - Variation EMEA/H/C/1215/II/2 (2011)2788 of 14/04/2011
18/04/2011 Centralised - Variation EMEA/H/C/1215/II/2 (2011)2789 of 14/04/2011
13/12/2011 Centralised - Variation EMEA/H/C/1215/N/5
Updated with Decision(2012)2186 of 26/03/2012
28/03/2012 Centralised - Variation EMEA/H/C/1215/II/7 (2012)2186 of 26/03/2012
25/04/2012 Centralised - Variation EMEA/H/C/1215/II/7 (2012)2816 of 20/04/2012
28/08/2012 Centralised - Variation EMEA/H/C/1215/II/9 (2012)6037 of 23/08/2012
25/04/2013 Centralised - Variation EMEA/H/C/1215/II/12
Updated with Decision(2013)4025 of 21/06/2013
25/06/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1215/T/13 (2013)4025 of 21/06/2013
13/11/2013 Centralised - Variation EMEA/H/C/1215/IA/17/G
15/11/2013 Centralised - Variation EMEA/H/C/1215/IB/18