Second Evaluation: 29 April 2014 About the Therapeutic Goods Administration (TGA) The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices. AusPAR Attachment 1 Extract from the Clinical Evaluation Report for Sevelamer hydrochloride Proprietary Product Name: Sevelamer GPPL, Sevelamer GxP, Sevelam, Sevlar, sevelamer, Apotex-sevelamer, Chemmart Genrx sevelamer, Terry White sevelamer Sponsor: Generic partners Pty Ltd The TGA administers the Therapeutic 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 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 <>. the Extract from the Clinical Evaluation Report
Second Evaluation: 29 April 2014 AusPAR Attachment 1 Extract from the Clinical Evaluation Report for Sevelamer hydrochloride Proprietary Product Name: Sevelamer GPPL, Sevelamer GxP, Sevelam, Sevlar, Apotex-sevelamer, Chemmart sevelamer, Genrx sevelamer, Terry White sevelamer Sponsor: Generic partners Pty Ltd About the Therapeutic Goods Administration (TGA) The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices. The TGA administers the Therapeutic 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 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 <>. the Extract from the Clinical Evaluation Report
auspar-sevelamer-hydrochloride-151105-cer_0.docx