Dronedarone for the treatment of non-permanent atrial fibrillation

Atrial fibrillation - dronedarone: review decision - October 2012 information

Appendix A: decision paper presented to the Institute's Guidance Executive

Appendix A: decision paper presented to the Institute's Guidance Executive (PDF 58 KB)

TA197 Atrial fibrillation - dronedarone: review proposal - July 2012 information

Appendix A: provisional matrix of stakeholders

Appendix A: provisional matrix of stakeholders (PDF 39 KB)

Appendix B: proposal paper presented to the Institute's Guidance Executive

Appendix B: proposal paper presented to the Institute's Guidance Executive (PDF 296 KB)

Atrial fibrillation - dronedarone: press release information

Download PDF version

Atrial fibrillation - dronedarone: final appraisal determination information

Atrial fibrillation - dronedarone: final appraisal determination

Atrial fibrillation - dronedarone: final appraisal determination (PDF 144 KB)

Atrial fibrillation - dronedarone: response to comments table

Atrial fibrillation - dronedarone: response to comments table (PDF 127 KB)

Atrial fibrillation - dronedarone: consultee and commentator comments on the ACD

Atrial fibrillation - dronedarone: Sanofi Aventis response

Atrial fibrillation - dronedarone: Sanofi Aventis response (PDF 68 KB)

Atrial fibrillation - dronedarone: Arrhythmia Alliance response

Atrial fibrillation - dronedarone: Arrhythmia Alliance response (PDF 19 KB)

Atrial fibrillation - dronedarone: Atrial Fibrillation Association response

Atrial fibrillation - dronedarone: Atrial Fibrillation Association response (PDF 6.5 KB)

Atrial fibrillation - dronedarone: Grown Up Congenital Heart Patient Association response

Atrial fibrillation - dronedarone: Grown Up Congenital Heart Patient Association response (PDF 73 KB)

Atrial fibrillation - dronedarone: Royal College of Nursing response

Atrial fibrillation - dronedarone: Royal College of Nursing response (PDF 54 KB)

Atrial fibrillation - dronedarone: The Stroke Association response

Atrial fibrillation - dronedarone: The Stroke Association response (PDF 9.4 KB)

Atrial fibrillation - dronedarone: Medicines and Healthcare Products Regulatory Agency response

Atrial fibrillation - dronedarone: appraisal consultation document 2

Atrial fibrillation - dronedarone: appraisal consultation document 2 information

Evaluation report

Non-manufacturer comments on the first ACD

Arrythmia Alliance

Arrythmia Alliance (PDF 29 KB)

Atrial Fibrillation Association 2

Atrial Fibrillation Association 2 (PDF 79 KB)

British Heart Foundation

British Heart Foundation (PDF 15 KB)

Heart Rhythm UK

Heart Rhythm UK (PDF 30 KB)

Primary Care Cardiovascular Society

Primary Care Cardiovascular Society (PDF 39 KB)

Department of Health

Department of Health (PDF 12 KB)

Report to the Appraisal Committee summarising public comments on the first ACD issued in December 2009 (including comments from patients, carers and health professionals)

Report to the Appraisal Committee summarising public comments on the first ACD issued in December 2009 (including comments from patients, carers and health professionals) (PDF 172 KB)

Expert comments on the first ACD

Jerrome 2

Jerrome 2 (PDF 68 KB)

Sulke 2

Sulke 2 (PDF 70 KB)

Evidence Review Group Exploratory Analyses

Evidence Review Group Exploratory Analyses (PDF 49 KB)

Sanofi Aventis

Atrial fibrillation - dronedarone: appraisal consultation document

Atrial fibrillation - dronedarone: appraisal consultation document information

Evaluation report

Pre-meeting briefing

Pre-meeting briefing (PDF 139 KB)

Evidence Review Group report

Evidence Review Group report (PDF 693 KB)

Clarification

Clarification (PDF 59 KB)

Response to clarification

Response to clarification (PDF 493 KB)

Manufacturer factual check of the Evidence Review Group report

Manufacturer factual check of the Evidence Review Group report (PDF 588 KB)

Non-manufacturer submissions

Atrial Fibrillation Association

Atrial Fibrillation Association (PDF 40 KB)

AntiCoagulation Europe

AntiCoagulation Europe (PDF 44 KB)

The Stroke Association

The Stroke Association (PDF 44 KB)

Manufacturer submission

Manufacturer submission (PDF 1.26 MB)

Expert written personal statements

Sulke

Sulke (PDF 183 KB)

Wolff

Wolff (PDF 43 KB)

Trivedi

Trivedi (PDF 35 KB)

Porter

Porter (PDF 27 KB)

Jerrome

Atrial fibrillation and atrial flutter - dronedarone: final scope

Atrial fibrillation and atrial flutter - dronedarone: final matrix of consultees and commentators

Atrial fibrillation and atrial flutter - dronedarone: response to comments on the draft scope

Atrial fibrillation and atrial flutter - dronedarone: response to comments on the provisional matrix

Atrial fibrillation and atrial flutter - dronedarone: draft scope

Atrial fibrillation and atrial flutter - dronedarone: provisional matrix of consultees and commentators - pre-referral