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:
| 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:
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| 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).