Date of second round CER: November 2013 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 Goods Act 1989 (the Act), applying a risk AusPAR Attachment 2 Extract from the Clinical Evaluation Report for lurasidone hydrochloride Proprietary Product Name: Latuda Sponsor: Commercial Eyes Pty Ltd 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 <>. About the Extract from the Clinical Evaluation Report This document provides more detail 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] indicate confidential information has been deleted. For the most recent Product Information (PI), please trial to the TGA website <>.
Date of second round CER: November 2013 AusPAR Attachment 2 Extract from the Clinical Evaluation Report for lurasidone hydrochloride Proprietary Product Name: Latuda Sponsor: Commercial Eyes 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 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 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 the Extract from the Clinical Evaluation Report This document provides more detail 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] indicate confidential information has been deleted. For the most recent Product Information (PI), please to the TGA website <>. trial
auspar-lurasidone-hydrochloride-140620-cer.docx