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:*	Abrilada (20mg/0.4mL pre-filled syringe)
Active Ingredient:	Adalimumab 50mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturer:	Catalent Indiana LLC, Indiana, United States of America

*Product:*	Abrilada (40mg/0.8mL pre-filled syringe)
Active Ingredient:	Adalimumab 50mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturer:	Catalent Indiana LLC, Indiana, United States of America

*Product:*	Abrilada (40mg/0.8mL pre-filled pen)
Active Ingredient:	Adalimumab 50mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturer:	Catalent Indiana LLC, Indiana, United States of America

*Product:*	Abrilada (40mg/0.8mL vial)
Active Ingredient:	Adalimumab 50mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturer:	Catalent Indiana LLC, Indiana, United States of America

*Product:*	Kesimpta (pre-filled pen)
Active Ingredient:	Ofatumumab 50mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Kesimpta (pre-filled syringe)
Active Ingredient:	Ofatumumab 50mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Risperidone-Teva
Active Ingredient:	Risperidone 25mg
Dosage Form:	Powder for injection with diluent
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	Pharmathen International SA, Rodopi, Greece

*Product:*	Risperidone-Teva
Active Ingredient:	Risperidone 37.5mg
Dosage Form:	Powder for injection with diluent
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	Pharmathen International SA, Rodopi, Greece

*Product:*	Risperidone-Teva
Active Ingredient:	Risperidone 50mg
Dosage Form:	Powder for injection with diluent
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	Pharmathen International SA, Rodopi, Greece

Dated this 23rd 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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