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:*	Leqvio
Active Ingredient:	Inclisiran sodium 200mg/mL equivalent to inclisiran 189mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Corden Pharma SpA, Caponago, Italy

*Product:*	Sugammadex Sandoz (200mg/2mL)
Active Ingredient:	Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Lek Pharmaceuticals d.d., Ljubljana, Slovenia

*Product:*	Sugammadex Sandoz (500mg/5mL)
Active Ingredient:	Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Lek Pharmaceuticals d.d., Ljubljana, Slovenia

*Product:*	Sugammadex Viatris (200mg/2mL)
Active Ingredient:	Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Viatris Limited
Manufacturer:	Mylan Laboratories Limited, Hosur, India

*Product:*	Sugammadex Viatris (500mg/5mL)
Active Ingredient:	Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Viatris Limited
Manufacturer:	Mylan Laboratories Limited, Hosur, India

Dated this 3rd day of April 2023.

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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