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:*	Allerclear
Active Ingredient:	Dexchlorpheniramine maleate 2mg
Dosage Form:	Tablet
New Zealand Sponsor:	AFT Pharmaceuticals Limited
Manufacturer:	Unison Pharmaceuticals Private Limited, Ahmedabad, India

*Product:*	Dimethyl Fumarate Sandoz
Active Ingredient:	Dimethyl fumarate 120mg
Dosage Form:	Modified release capsule
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Zaklady Farmaceutyczny Polypharma S.A., Nowa Deba, Poland

*Product:*	Dimethyl Fumarate Sandoz
Active Ingredient:	Dimethyl fumarate 240mg
Dosage Form:	Modified release capsule
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Zaklady Farmaceutyczny Polypharma S.A., Nowa Deba, Poland

*Product:*	Heartburn & Acid Reflux Relief
Active Ingredient:	Omeprazole 20mg
Dosage Form:	Modified release capsule
New Zealand Sponsor:	Maple Healthcare Limited
Manufacturer:	Laboratorios Liconsa SA, Guadalajara, Spain

*Product:*	ILARIS
Active Ingredient:	Canakinumab 150mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Paracetamol and Ibuprofen (Ethics) (General Sale)
Active Ingredients:	Ibuprofen 200mg Paracetamol 500mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Multichem NZ Limited
Manufacturer:	Milan Laboratories (India) Pvt Limited, Mumbai, India

*Product:*	Paracetamol and Ibuprofen (Ethics) (Pharmacy Only)
Active Ingredients:	Ibuprofen 200mg Paracetamol 500mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Multichem NZ Limited
Manufacturer:	Milan Laboratories (India) Pvt Limited, Mumbai, India

*Product:*	Paracetamol and Ibuprofen (Signature Range) (General Sale)
Active Ingredients:	Ibuprofen 200mg Paracetamol 500mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Multichem NZ Limited
Manufacturer:	Milan Laboratories (India) Pvt Limited, Mumbai, India

*Product:*	Paracetamol and Ibuprofen (Signature Range) (Pharmacy Only)
Active Ingredients:	Ibuprofen 200mg Paracetamol 500mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Multichem NZ Limited
Manufacturer:	Milan Laboratories (India) Pvt Limited, Mumbai, India

*Product:*	Pregabalin-AFT
Active Ingredient:	Pregabalin 20mg/mL
Dosage Form:	Oral solution
New Zealand Sponsor:	AFT Pharmaceuticals Limited
Manufacturer:	Chanelle Medical Limited, Galway, Ireland

Dated this 5th 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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