AusPAR: Ivabradine - Therapeutic Goods Administration

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AusPAR Coralan Ivabradine Servier Laboratories (Australia) Pty Ltd PM-2010-03269-3 Final 31 October 2012 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices. • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. • The work of the TGA is based on applying scientific and clinical expertise to decisionmaking, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. • To report a problem with a medicine or medical device, please see the information on the TGA website . About AusPARs • An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. • AusPARs are prepared and published by the TGA. • An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. • An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time. • A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA. Copyright © Commonwealth of Australia 2012 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 specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to . Page 2 of 101
Contents AusPAR Coralan Ivabradine Servier Laboratories (Australia) Pty Ltd PM-2010-03269-3-3 Final 31 October 2012 Therapeutic Goods Administration I. Introduction to product submission _____________________________________ 4 Submission details ____________________________________________________________________ 4 Product background __________________________________________________________________ 5 Regulatory status _____________________________________________________________________ 6 Product Information__________________________________________________________________ 6 II. Quality findings _____________________________________________________________ 6 III. Nonclinical findings _______________________________________________________ 6 IV. Clinical findings ____________________________________________________________ 6 Introduction ___________________________________________________________________________ 6 Pharmacokinetics _____________________________________________________________________ 8 Pharmacodynamics___________________________________________________________________ 8 Efficacy ________________________________________________________________________________ 8 Safety _________________________________________________________________________________ 36 Clinical Summary and Conclusions _________________________________________________ 49 List of Questions _____________________________________________________________________ 58 Second Round Evaluation of Clinical Data Submitted in Response to Clinical Questions _____________________________________________________________________________ 58 V. Pharmacovigilance findings ____________________________________________ 66 Risk management plan ______________________________________________________________ 66 VI. Overall conclusion and risk/benefit assessment __________________ 70 Quality ________________________________________________________________________________ 71 Nonclinical ___________________________________________________________________________ 71 Clinical ________________________________________________________________________________ 71 Risk management plan ______________________________________________________________ 85 Risk-benefit analysis ________________________________________________________________ 85 Outcome ____________________________________________________________________________ 100 Attachment 1. Product Information ___________________________________100 Page 3 of 101
Page 1: Australian Public Assessment Report
Page 5 and 6: Product background AusPAR Coralan I
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Second round benefit-risk assessmen
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Safety specification AusPAR Coralan
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CL3-067 (Follow up Measure; Ophthal
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Risk management plan AusPAR Coralan
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Table 35 AusPAR Coralan Ivabradine
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Therapeutic Goods Administration PO
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AusPAR: Ivabradine - Therapeutic Goods Administration

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