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:*	DAYVIGO
Active Ingredient:	Lemborexant 5mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Eisai New Zealand Limited
Manufacturer:	Eisai Manufacturing Limited, Hatfield, United Kingdom

*Product:*	DAYVIGO
Active Ingredient:	Lemborexant 10mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Eisai New Zealand Limited
Manufacturer:	Eisai Manufacturing Limited, Hatfield, United Kingdom

*Product:*	Metoclopramide HCl (Medicianz)
Active Ingredient:	Metoclopramide hydrochloride 10mg
Dosage Form:	Solution for injection
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	Maiva Pharma Private Limited, Hosur, India

*Product:*	Metoclopramide HCl (Medsurge)
Active Ingredient:	Metoclopramide hydrochloride 10mg
Dosage Form:	Solution for injection
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	Maiva Pharma Private Limited, Hosur, India

*Product:*	PipTaz 2/0.25 (Medicianz)
Active Ingredients:	Piperacillin monohydrate 2g equivalent to piperacillin sodium 2.085g Tazobactam 0.25g equivalent to tazobactam sodium 0.268g
Dosage Form:	Powder for injection
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	Fresenius Kabi iPSUM S.r.l, Villadose, Italy

*Product:*	PipTaz 2/0.25 (Medsurge)
Active Ingredients:	Piperacillin monohydrate 2g equivalent to piperacillin sodium 2.085g Tazobactam 0.25g equivalent to tazobactam sodium 0.268g
Dosage Form:	Powder for injection
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	Fresenius Kabi iPSUM S.r.l, Villadose, Italy

*Product:*	PipTaz 4/0.5 (Medicianz)
Active Ingredients:	Piperacillin monohydrate 4g equivalent to piperacillin sodium 4.170g Tazobactam 0.5g equivalent to tazobactam sodium 0.536g
Dosage Form:	Powder for injection
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	Fresenius Kabi iPSUM S.r.l, Villadose, Italy

*Product:*	PipTaz 4/0.5 (Medsurge)
Active Ingredients:	Piperacillin monohydrate 4g equivalent to piperacillin sodium 4.170g Tazobactam 0.5g equivalent to tazobactam sodium 0.536g
Dosage Form:	Powder for injection
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	Fresenius Kabi iPSUM S.r.l, Villadose, Italy

*Product:*	Tevimbra
Active Ingredient:	Tislelizumab 10mg/mL
Dosage Form:	Concentrate for injection
New Zealand Sponsor:	BeiGene NZ Unlimited
Manufacturer:	Boehringer Ingelheim Biopharmaceuticals (China) Limited, Shanghai, China

*Product:*	Winlevi
Active Ingredient:	Clascoterone 1%w/w
Dosage Form:	Topical cream
New Zealand Sponsor:	CARSL Consulting
Manufacturer:	Cosmo SpA, Milan, Italy

Dated this 2nd day of December 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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