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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

*Product:*	Contrave 8/90
Active Ingredients:	Bupropion hydrochloride 90mg equivalent to bupropion 78mg Naltrexone hydrochloride 8mg equivalent to naltrexone 7.2mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	iNova Pharmaceuticals (New Zealand) Limited
Manufacturer:	Patheon Inc, Whitby, Canada

*Product:*	Dexmedetomidine Mylan
Active Ingredient:	Dexmedetomidine hydrochloride 0.118mg/mL equivalent to dexmedetomidine 0.100mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Viatris Limited
Manufacturer:	Mylan Teoranta Limited, Inverin, Ireland

*Product:*	Medical Nitrous Oxide
Active Ingredient:	Nitrous oxide 100%
Dosage Form:	Gas
New Zealand Sponsor:	Air Liquide New Zealand Limited
Manufacturers:	Air Liquide New Zealand Limited, Auckland, New Zealand BOC Limited, Auckland, New Zealand

*Product:*	Mvasi (100mg/4mL)
Active Ingredient:	Bevacizumab 25mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Amgen New Zealand Limited
Manufacturers:	Patheon Manufacturing Services LLC, North Carolina, United States of America Amgen Manufacturing Limited, Juncos, Puerto Rico
Note: The application received 14 May 2021 is for the finished product changes

*Product:*	Mvasi (400mg/16mL)
Active Ingredient:	Bevacizumab 25mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Amgen New Zealand Limited
Manufacturers:	Patheon Manufacturing Services LLC, North Carolina, United States of America Amgen Manufacturing Limited, Juncos, Puerto Rico
Note: The application received 14 May 2021 is for the finished product changes

*Product:*	Mvasi (100mg/4mL)
Active Ingredient:	Bevacizumab 25mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Amgen New Zealand Limited
Manufacturers:	Patheon Manufacturing Services LL, North Carolina, United States of America Amgen Manufacturing Limited, Juncos, Puerto Rico
Note: The application received 30 June 2021 is for the active ingredient changes

*Product:*	Mvasi (400mg/16mL)
Active Ingredient:	Bevacizumab 25mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Amgen New Zealand Limited
Manufacturers:	Patheon Manufacturing Services LLC, North Carolina, United States of America Amgen Manufacturing Limited, Juncos, Puerto Rico
Note: The application received 30 June 2021 is for the active ingredient changes

Dated this 9th day of August 2022.

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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