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:*	Bisacodyl-AFT
Active Ingredient:	Bisacodyl 5mg
Dosage Form:	Enteric coated tablet
New Zealand Sponsor:	Neo Pharma Limited
Manufacturer:	GPAX Pharmaceuticals Private Limited, Daman, India

*Product:*	Estrogel
Active Ingredient:	Estradiol hemihydrate 0.62mg/g equivalent to anhydrous estradiol 0.60mg/g
Dosage Form:	Transdermal gel
New Zealand Sponsor:	Pharmaco (NZ) Limited
Manufacturer:	Besins Manufacturing Belgium, Drogenbos, Belgium

*Product:*	Metronidazole (Medicianz)
Active Ingredient:	Metronidazole 5mg/mL
Dosage Form:	Solution for infusion
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	POLIFARMA ILAC SAN.VE. TIC A.S., Tekirdag, Turkey

*Product:*	Metronidazole (Medsurge)
Active Ingredient:	Metronidazole 5mg/mL
Dosage Form:	Solution for infusion
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	POLIFARMA ILAC SAN.VE. TIC A.S., Tekirdag, Turkey

*Product:*	Neo Bisacodyl
Active Ingredient:	Bisacodyl 5mg
Dosage Form:	Enteric coated tablet
New Zealand Sponsor:	Neo Pharma Limited
Manufacturer:	GPAX Pharmaceuticals Private Limited, Daman, India

*Product:*	Sugammadex-Teva (200mg/2mL)
Active Ingredient:	Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	PLIVA Croatia Limited, Zagreb, Croatia

*Product:*	Sugammadex-Teva (500mg/5mL)
Active Ingredient:	Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	PLIVA Croatia Limited, Zagreb, Croatia

*Product:*	Tezspire (Pre-filled syringe)
Active Ingredient:	Tezepelumab 110mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	AstraZeneca Limited
Manufacturer:	Amgen Manufacturing Limited, Juncos, Puerto Rico

*Product:*	Tezspire (Pre-filled Pen)
Active Ingredient:	Tezepelumab 110mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	AstraZeneca Limited
Manufacturer:	Amgen Manufacturing Limited, Juncos, Puerto Rico

*Product:*	Vildagliptin
Active Ingredient:	Vildagliptin 50mg
Dosage Form:	Tablet
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

Dated this 13th day of May 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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