Atrial fibrillation - dronedarone: review decision - October 2012 information
History
A list of downloadable documents created during development.
Background information
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Appendix A: decision paper presented to the Institute's Guidance Executive (PDF 58 KB)
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TA197 Atrial fibrillation - dronedarone: review proposal - July 2012 information
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Appendix B: proposal paper presented to the Institute's Guidance Executive (PDF 296 KB)
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Atrial fibrillation - dronedarone: press release information
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Atrial fibrillation - dronedarone: final appraisal determination
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Atrial fibrillation - dronedarone: final appraisal determination information
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Atrial fibrillation - dronedarone: final appraisal determination (PDF 144 KB)
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Atrial fibrillation - dronedarone: response to comments table (PDF 127 KB)
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Atrial fibrillation - dronedarone: consultee and commentator comments on the ACD
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Atrial fibrillation - dronedarone: Sanofi Aventis response (PDF 68 KB)
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Atrial fibrillation - dronedarone: Arrhythmia Alliance response (PDF 19 KB)
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Atrial fibrillation - dronedarone: Atrial Fibrillation Association response (PDF 6.5 KB)
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Atrial fibrillation - dronedarone: Royal College of Nursing response (PDF 54 KB)
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Atrial fibrillation - dronedarone: The Stroke Association response (PDF 9.4 KB)
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Atrial fibrillation - dronedarone: appraisal consultation document 2
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Atrial fibrillation - dronedarone: appraisal consultation document 2
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Atrial fibrillation - dronedarone: appraisal consultation document 2 information
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Evaluation report
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Non-manufacturer comments on the first ACD
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Expert comments on the first ACD
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Atrial fibrillation - dronedarone: appraisal consultation document
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Atrial fibrillation - dronedarone: appraisal consultation document
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Atrial fibrillation - dronedarone: appraisal consultation document information
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Evaluation report
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Manufacturer factual check of the Evidence Review Group report (PDF 588 KB)
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Non-manufacturer submissions
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Expert written personal statements
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