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:*	Levodopa/Carbidopa
Active Ingredients:	Carbidopa monohydrate 27mg equivalent to carbidopa 25mg Levodopa 100mg
Dosage Form:	Tablet
New Zealand Sponsor:	Orion Pharma (NZ) Limited
Manufacturer:	Orion Corporation, Espoo, Finland

*Product:*	Lorazepam-AFT
Active Ingredient:	Lorazepam 2mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	AFT Pharmaceuticals Limited
Manufacturer:	Wytwornia Surowic i Szczepionek BIOMED Sp. z o.o., Warsaw, Poland

*Product:*	Lorazepam-AFT
Active Ingredient:	Lorazepam 4mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	AFT Pharmaceuticals Limited
Manufacturer:	Wytwornia Surowic i Szczepionek BIOMED Sp. z o.o., Warsaw, Poland

*Product:*	PFIZER DAUNORUBICIN
Active Ingredient:	Daunorubicin hydrochloride 20mg equivalent to daunorubicin 18.7mg
Dosage Form:	Powder for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturer:	Corden Pharma Latina SpA, Sermoneta Latina, Italy

*Product:*	Phentermine Lupin
Active Ingredient:	Phentermine hydrochloride 18.75mg equivalent to phentermine 15mg
Dosage Form:	Modified release capsule
New Zealand Sponsor:	Aria Consulting Limited
Manufacturer:	Lupin Limited, Mihan, India

*Product:*	Phentermine Lupin
Active Ingredient:	Phentermine hydrochloride 37.5mg equivalent to phentermine 30mg
Dosage Form:	Modified release capsule
New Zealand Sponsor:	Aria Consulting Limited
Manufacturer:	Lupin Limited, Mihan, India

*Product:*	Stelara (45mg/0.5mL)
Active Ingredient:	Ustekinumab 90mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Janssen-Cilag (New Zealand) Limited
Manufacturers:	Cilag AG, Schaffhausen, Switzerland Baxter Pharmaceutical Solutions LLC, Indiana, United States of America

*Product:*	Stelara (90mg/1mL)
Active Ingredient:	Ustekinumab 90mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Janssen-Cilag (New Zealand) Limited
Manufacturers:	Cilag AG, Schaffhausen, Switzerland Baxter Pharmaceutical Solutions LLC, Indiana, United States of America

*Product:*	Tofacitinib Devatis
Active Ingredient:	Tofacitinib citrate 8.08mg equivalent to tofacitinib 5mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Tekirdag, Turkey

Dated this 8th day of November 2024.

MATTHEW SPENCER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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