Extract from the Clinical Evaluation Report for exenatide：从那临床评估报告提取物.doc

First round CER: November 2011 Second round CER: May 2012 AusPAR Attachment 2 Extract from the Clinical Evaluation Report for exenatide Proprietary Product Name: Byetta Sponsor: Eli Lilly Australia Pty Ltd 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 decision-making, 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 .au. About the Extract from the Clinical Evaluation Report This document provides a more detailed evaluation of the clinical findings, extracted from the Clinical Evaluation Report (CER) prepared by the TGA. This extract does not include sections from the CER regarding product documentation or post market activities. The words [Information redacted], where they appear in this document, indicate that confidential information has been deleted. For the most recent Product Information (PI), please refer to the TGA website .au/hp/information-medicines-pi.htm. Copyright? Commonwealth of Australia 2013This 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 org