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:*	Abiraterone - Teva
Active Ingredient:	Abiraterone acetate 500mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	Teva Pharmaceutical Industries Limited, Kfar Saba, Israel

*Product:*	AdiraMedica Paracetamol 500mg and Caffeine 65mg (General sale)
Active Ingredients:	Caffeine 65mg Paracetamol 500mg
Dosage Form:	Soft gelatin capsule
New Zealand Sponsor:	AdiraMedica Pty Limited
Manufacturer:	Softgel Healthcare Pvt. Limited, Pudupakkam Village, India

*Product:*	AdiraMedica Paracetamol 500mg and Caffeine 65mg (Pharmacy only)
Active Ingredients:	Caffeine 65mg Paracetamol 500mg
Dosage Form:	Soft gelatin capsule
New Zealand Sponsor:	AdiraMedica Pty Limited
Manufacturer:	Softgel Healthcare Pvt. Limited, Pudupakkam Village, India

*Product:*	Zolgensma (8.3mL vial)
Active Ingredient:	Onasemnogene abeparvovec 20TVG/mL
Dosage Form:	Solution for infusion
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Gene Therapies, Inc., Illinois, United States of America

*Product:*	Zolgensma (5.5mL vial + 8.3mL vial)
Active Ingredient:	Onasemnogene abeparvovec 20TVG/mL
Dosage Form:	Solution for infusion
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Gene Therapies, Inc., Illinois, United States of America

Dated this 7th day of February 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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