Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

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*Product:*	FluoroDose (Bubble Gum flavour)
Active Ingredient:	Sodium fluoride 5%w/w
Dosage Form:	Dental suspension
New Zealand Sponsor:	CARSL Consulting
Manufacturer:	Young Dental Manufacturing Co 1 LLC, Missouri, United States of America

*Product:*	FluoroDose (Caramel flavour)
Active Ingredient:	Sodium fluoride 5%w/w
Dosage Form:	Dental suspension
New Zealand Sponsor:	CARSL Consulting
Manufacturer:	Young Dental Manufacturing Co 1 LLC, Missouri, United States of America

*Product:*	FluoroDose (Cherry flavour)
Active Ingredient:	Sodium fluoride 5%w/w
Dosage Form:	Dental suspension
New Zealand Sponsor:	CARSL Consulting
Manufacturer:	Young Dental Manufacturing Co 1 LLC, Missouri, United States of America

*Product:*	FluoroDose (Melon flavour)
Active Ingredient:	Sodium fluoride 5%w/w
Dosage Form:	Dental suspension
New Zealand Sponsor:	CARSL Consulting
Manufacturer:	Young Dental Manufacturing Co 1 LLC, Missouri, United States of America

*Product:*	FluoroDose (Mint flavour)
Active Ingredient:	Sodium fluoride 5%w/w
Dosage Form:	Dental suspension
New Zealand Sponsor:	CARSL Consulting
Manufacturer:	Young Dental Manufacturing Co 1 LLC, Missouri, United States of America

*Product:*	FluoroDose (Combinations flavours (Cherry, Mint, Caramel, Bubble Gum and Melon))
Active Ingredient:	Sodium fluoride 5%w/w
Dosage Form:	Dental suspension
New Zealand Sponsor:	CARSL Consulting
Manufacturer:	Young Dental Manufacturing Co 1 LLC, Missouri, United States of America

*Product:*	Kirsty (pre-filled pen)
Active Ingredient:	Insulin aspart 100U/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Maxx Pharma NZ Limited
Manufacturer:	Biocon Sdn Bhd, Iskandar Puteri, Malaysia

*Product:*	Kirsty (vial)
Active Ingredient:	Insulin aspart 100U/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Maxx Pharma NZ Limited
Manufacturer:	Biocon Sdn Bhd, Iskandar Puteri, Malaysia

Dated this 10th 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).

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