Drug Monitoring

Follow the links below to find information on post market monitoring of the safety of drugs.

Created Sept 2007

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8 Resources Found
Results 1 to 8 displayed.
Title:   Safety alerts and advisory statements
Publisher:   Australian Government Department of Health and Ageing
Description:   Links to safety alerts and advisory statements about medicines and medical devices in Australia.
Date:   Aug 2008
Title:   Zolpidem ("Stilnox") - updated information - February 2008
Publisher:   Australian Government Department of Health and Ageing
Description:   As a response to these observed adverse effects, significant changes have been made to the Product Information (PI) and Consumer Medicine Information (CMI) documents for products containing zolpidem.
Date:   Feb 2008
Title:   Dental notes - reporting adverse reactions
Publisher:   Australian Prescriber
Description:   Dentists may well be in a unique position to be able to assess potential adverse reactions to the medication that we prescribe and that prescribed by our medical colleagues.
Date:   Dec 2005
Title:   Comments for consumers - reporting adverse reactions
Publisher:   Australian Prescriber
Description:   To increase information about medicines' safety, health professionals report side effects to the Adverse Drug Reactions Unit of the Therapeutic Goods Administration. These reports are assessed to see if problems are emerging. In some cases medicines have been restricted for use, or banned for safety reasons.
Date:   Dec 2005
Title:   Showing the blue card: reporting adverse reactions
Publisher:   Australian Prescriber
Description:   Reports of suspected adverse drug reactions are sent to the Adverse Drug Reactions Unit of the Therapeutic Goods Administration. Selected reports are forwarded to the Adverse Drug Reactions Advisory Committee which can recommend actions ranging from no action to the withdrawal of a drug from the market.
Date:   Dec 2005
Title:   Australian pharmacovigilance guideline
Publisher:   Australian Government Department of Health and Ageing
Description:   The Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by Drug Safety and Evaluation Branch (July 2003) has been amended to reflect changes that have occurred to EU pharmacovigilance reporting documentation.
Date:   May 2005
Title:   Australian medical devices guidelines: Postmarket activities. Guidance document number 11
Publisher:   Australian Government Department of Health and Ageing
Description:   This guidance document describes the obligations and responsibilities of sponsors and manufacturers of medical devices after medical devices have been approved for supply in Australia.
Date:   Aug 2003
Title:   TGA Office of Laboratories and Scientific Services
Publisher:   Australian Government Department of Health and Ageing
Description:   Information on the role, organisation, and activities of the TGA Office of Laboratories and Scientific Services.
Date:   Jun 2003
Results 1 to 8 displayed.