About the Therapeutic Goods Administration (TGA) The Therapeutic Trial 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 Trial 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. Australian Public Assessment Report for liraglutide Proprietary Product Name: Saxenda Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd 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 <>. AusPARs An Australian Public Assessment Report (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; it provides 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.
Australian Public Assessment Report for liraglutide Proprietary Product Name: Saxenda Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd About the Therapeutic Goods Administration (TGA) The Therapeutic 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 <>. AusPARs An Australian Public Assessment Report (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; it provides 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. Trial Trial
auspar-liraglutide-160323.docx