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Cox 2 inhibitors - Media advisory 15 March 2005

Cox 2 inhibitors
Media advisory 15 March 2005

As indicated at a media conference earlier this month the Medicines Adverse Reaction Committee - MARC - is meeting today to determine its final recommendations to the Minister of Health on Cox 2 inhibitors. It will be considering new data submitted by pharmaceutical companies as well as research published since we gave our inital advice.

Please be advised that neither the committee nor the Ministry will be making any statement during or immediately following the meeting, as MARC's recommendations will go through normal process as outlined in the attch diagram.

In the interim Medsafe advises that the advice given to prescribers, and outlined in media statements still stands.


********

Process for MARC


Data submitted to Medsafe from sponsors
(i.e. pharmaceutical companies)
+
Studies published in the medical literature
+
Local and international reports of adverse events

Reviewed by MARC
Recommendations made by the committee


Minutes of meeting are recorded


MARC members and Chair ratify minutes

Medsafe reviews recommendations and provides comment
Recommendations as detailed in the minutes and Medsafe’s comments are forwarded to the Minister


Minister/Minister’s delegate accepts (or otherwise) the recommendations


Medsafe implements recommendations. This may include:
- regulatory action involving the product sponsors
- dissemination of information to prescribers
- provision of advice for consumers


ENDS

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