1.

Welcome

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Apologies

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Declaration of conflicts of interest

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 Kleerkol (mannitol 100 g/750 mL), powder for oral solution (AFT Pharmaceuticals)

Kleerkol is a powder for oral solution containing the active ingredient mannitol (100 g/750 mL). Kleerkol is indicated for use in adults before clinical procedures requiring a clean bowel, such as endoscopy or x-ray examinations.

This application is being referred to the Medicines Assessment Advisory Committee (the Committee) for independent advice as to whether the Minister of Health (or their delegate) should grant consent for sale, supply and distribution of the proposed product in Aotearoa New Zealand. The Committee is also asked to consider the classification of mannitol and whether referral to the Medicines Classification Committee is warranted.

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REVIEW OF MEDICINE EVALUATIONS

A term of reference for the Committee is that the Committee should review evaluation reports and provide expert advice to Medsafe and the Minister of Health as to the quality of the risk-benefit assessments that have been completed.

The Committee will review the evaluation reports of 12 applications for the Minister of Health’s consent or provisional consent for the distribution of new medicines.

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GENERAL BUSINESS

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DATE OF NEXT MEETING