June 2014 Australian Public Assessment Report for Bimatoprost Proprietary Product Name: Latisse Sponsor: Allergan Australia Pty Ltd About the Therapeutic Goods Administration (tga)



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June 2014
Australian Public Assessment Report for Bimatoprost

Proprietary Product Name: Latisse

Sponsor: Allergan Australia 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 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 .

About AusPARs

  • An 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 2014


This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to .
Contents

List of commonly used abbreviations 7

I. Introduction to product submission 9

Submission details 9

Product background 10

Regulatory status 10



II. Quality findings 10

Introduction 10

Drug substance (active ingredient) 10

Drug product 11

Biopharmaceutics 11

Quality summary and conclusions 11



III. Nonclinical findings 11

Introduction 11

Pharmacology 12

Pharmacokinetics 12

Toxicology 13

Nonclinical summary and conclusions 14



IV. Clinical findings 14

Introduction 15

Pharmacokinetics 16

Pharmacodynamics 16

Dosage selection for the pivotal studies 17

Efficacy 17

Safety 19

First round recommendation regarding authorisation 27

Clinical questions 28

Second round evaluation of clinical data submitted in response to questions 29

Second round recommendation regarding authorisation 40

V. Pharmacovigilance findings 40

Risk management plan 40



VI. Overall conclusion and risk/benefit assessment 46

Quality 46

Nonclinical 46

Clinical 47

Risk management plan 55

Risk-benefit analysis 55



Attachment 1. Extract from the Clinical Evaluation Report 74


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