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:

Schedule

*Product:*	Histoleve
Active Ingredient:	Fluticasone propionate 0.5mg/g
Dosage Form:	Nasal spray suspension
New Zealand Sponsor:	AFT Pharmaceuticals Limited
Manufacturer:	Jewim Pharmaceutical (Shandong) Co., Limited, Shandong Province, China

*Product:*	Nubeqa
Active Ingredient:	Darolutamide 300mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Bayer New Zealand Limited
Manufacturer:	Orion Corporation, Espoo, Finland

*Product:*	Oxycodone HCl (10mg/1mL) (Medicianz)
Active Ingredient:	Oxycodone hydrochloride 10mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Medicianz Healthcare Limited
Manufacturer:	HBM Pharma s.r.o., Martin, Slovakia

*Product:*	Oxycodone HCl (10mg/1mL) (Medsurge)
Active Ingredient:	Oxycodone hydrochloride 10mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Medicianz Healthcare Limited
Manufacturer:	HBM Pharma s.r.o., Martin, Slovakia

*Product:*	Oxycodone HCl (20mg/2mL) (Medicianz)
Active Ingredient:	Oxycodone hydrochloride 10mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Medicianz Healthcare Limited
Manufacturer:	HBM Pharma s.r.o., Martin, Slovakia

*Product:*	Oxycodone HCl (20mg/2mL) (Medsurge)
Active Ingredient:	Oxycodone hydrochloride 10mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Medicianz Healthcare Limited
Manufacturer:	HBM Pharma s.r.o., Martin, Slovakia

*Product:*	Oxycodone HCl (Medicianz)
Active Ingredient:	Oxycodone hydrochloride 50mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Medicianz Healthcare Limited
Manufacturer:	HBM Pharma s.r.o., Martin, Slovakia

*Product:*	Oxycodone HCl (Medsurge)
Active Ingredient:	Oxycodone hydrochloride 50mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Medicianz Healthcare Limited
Manufacturer:	HBM Pharma s.r.o., Martin, Slovakia

Dated this 9th day of September 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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