Australian public assessment forSitagliptin Metformin澳大利公众评价forsitagliptin二甲双胍.docxVIP

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Australian public assessment forSitagliptin Metformin澳大利公众评价forsitagliptin二甲双胍.docx

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Australian public assessment forSitagliptin Metformin澳大利公众评价forsitagliptin二甲双胍

January 2013Australian Public Assessment Report for Sitagliptin/MetforminProprietary Product Name: JanumetSponsor: MSD (Australia) Pty LimitedAbout 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 AusPARsAn 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 2013This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if yo