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Review of the management of adverse events associated with Panvax and Fluvax Professor John Horvath ao mbbs fracp Final Report 10 March 2011
Review of the management of adverse events associated with Panvax and Fluvax Print ISBN 978-1-74241-463-8 Online: 978-1-74241-464-5 Publications Number: D0371 Paper-based publications © Commonwealth of Australia 2011 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Communications Branch, Department of Health and Ageing, GPO Box 9848, Canberra ACT 2601, or via e-mail to copyright@health.gov.au. Internet sites © Commonwealth of Australia Year This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Communications Branch, Department of Health and Ageing, GPO Box 9848, Canberra ACT 2601, or via e-mail to copyright@health.gov.au.
Page 1: Review of the management of adverse
Page 5 and 6: 5.9 Seasonal influenza vaccination
Page 7 and 8: MedDRA Medsafe NCIRS NIBSC NIC NIS
Page 9 and 10: The Review has found that the Austr
Page 11 and 12: Recommendation 4 Raising Community
Page 13 and 14: WA Minister for Health, the Hon Dr
Page 16 and 17: 3 THE AUSTRALIAN REGULATORY SYSTEM
Page 18 and 19: • the health professionals who ad
Page 20 and 21: 3.4 International post-market surve
Page 22: and others by providing information
Page 25 and 26: is an agency of the Department and
Page 28 and 29: 5 INFLUENZA AND THE ROLE OF IMMUNIS
Page 30 and 31: there was some evidence of cross pr
Page 32 and 33: TGA published summary reports on th
Page 34 and 35: 6 THE FINDINGS OF THE REVIEW 6.1 Ra
Page 36 and 37: Table 1. Timeline of the investigat
Page 38 and 39: the TGA requested case report infor
Page 40 and 41: 6.2.2 Were the actions of the Commo
Page 42 and 43: iii. restructuring immunisation gov
Page 44 and 45: There was a perception among some s
Page 46 and 47: 7 RECOMMENDATIONS OF THE REVIEW Rec
Page 48 and 49: 8 REFERENCES Australian Government
Page 50 and 51: APPENDICES Appendix I: Documents an
Page 52 and 53:
Appendix II: People interviewed •
Page 54 and 55:
Country Canada Regulatory Agency an
Page 56 and 57:
Regulatory Agency and Country Relev
Page 59:
www.health.gov.au All information i
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