Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

*Product:*	Topamine
Active Ingredient:	Silver diamine fluoride 38%w/v equivalent to silver 25%w/v, fluoride 4.5%
Dosage Form:	Topical solution
New Zealand Sponsor:	Henry Schein Regional Limited
Manufacturer:	Dentalife Australia Pty Limited, Melbourne, Australia
Note: This consent is given subject to the following condition: The medicine may only be marketed or distributed when no other topical silver diamine fluoride product for dental use with consent under section 20 of the Medicines Act 1981, is available in the New Zealand market, or to meet PHARMAC supply obligations.
Note: This consent is valid for two years from the date of publication of this notice.

Dated this 3rd day of September 2024.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

Provisional Consent to the Distribution of a New Medicine

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