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Guidelines and Codes

Products Containing Paracetamol - Revised Guideline

Added to web site: May 2002

Medsafe wish to announce that, following a review of the current Paracetamol guideline:

1. The guideline for paracetamol in combination products to be adopted by Medsafe, effective immediately, is as follows:

   Combination products

   Products containing more than one active ingredient which are similar to existing registered products will usually not require efficacy or safety data, provided the combination is already routinely used. Where new combinations are proposed the safety and efficacy of the combination will need to be justified. Due to the lack of flexibility when dosing with combination products and because the majority of patients require more than 500 mg of paracetamol for effective analgesia, products should be formulated so that doses of other ingredients are at safe and effective levels when at least 600 mg of paracetamol is taken, but no unit dose contains more than 500mg paracetamol. Please note that the current classification status regarding paracetamol remains unchanged.

2. Medsafe propose to update the current NZ Paracetamol guideline. In the interim the current guideline as published in the New Zealand Regulatory Guidelines for Medicines, Volume 1, 5th Edition, October 2001, remains in force.  It is anticipated that the new NZ guideline will be based on the guideline proposed by the TGA and MEC once discussion on the Newgreen Report review reaches resolution.  The Newgreen Report and the Review of this Report can be viewed at the TGA web address given as follows: http://www.health.gov.au/tga/docs/html/analgupd.htm.   The draft NZ guideline is proposed to be made available for consultation prior to its adoption by Medsafe.