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 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 .
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.
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Common abbreviations 7
I. Introduction to product submission 10
Submission details 10
Product background 11
Regulatory status 13
Product Information 14
II. Quality findings 14
Active ingredients 14
Drug product 16
Quality summary and conclusions 21
III. Nonclinical findings 22
Nonclinical summary and conclusions 45
IV. Clinical findings 63
Clinical rationale 63
Dosage selection for the pivotal studies 69
First round benefit-risk assessment 75
First round recommendation regarding authorisation 81
Clinical questions 81
V. Pharmacovigilance findings 81
Risk management plan 81
VI. Overall conclusion and risk/benefit assessment 90
Risk management plan 117
Risk-benefit analysis 118
Attachment 1. Product Information 133
Attachment 2. Extract from the Clinical Evaluation Report 133