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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

*Product:*	Actilyse
Active Ingredient:	Alteplase 10mg
Dosage Form:	Powder for injection
New Zealand Sponsor:	Boehringer Ingelheim (NZ) Limited
Manufacturer:	Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany

*Product:*	Actilyse
Active Ingredient:	Alteplase 20mg
Dosage Form:	Powder for injection
New Zealand Sponsor:	Boehringer Ingelheim (NZ) Limited
Manufacturer:	Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany

*Product:*	Actilyse
Active Ingredient:	Alteplase 50mg
Dosage Form:	Powder for injection
New Zealand Sponsor:	Boehringer Ingelheim (NZ) Limited
Manufacturer:	Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany

*Product:*	Bexsero
Active Ingredients:	Neisseria meningitidis group B factor H binding protein fusion protein 50mcg Neisseria meningitidis group B neisseria adhesin A protein 50mcg Neisseria meningitidis group B neisseria heparin binding antigen fusion protein 50mcg Neisseria meningitidis sergroup B outer membrane vesicles 25mcg
Dosage Form:	Suspension for injection
New Zealand Sponsor:	GlaxoSmithKline NZ Limited
Manufacturers:	GlaxoSmithKline Vaccines SRL, Sovicille, Italy Novartis Pharmaceutical Manufacturing GmbH, Kundl, Austria

*Product:*	Fluad Quad
Active Ingredients:	Influenza virus A (H1N1) haemagglutinin 15mcg Influenza virus A (H3N2) haemagglutinin 15mcg Influenza virus B (Victoria) haemagglutinin 15mcg Influenza virus B (Yamagata) haemagglutinin 15mcg
Dosage Form:	Suspension for injection
New Zealand Sponsor:	Seqirus (NZ) Limited
Manufacturer:	Seqirus Vaccines Limited, Liverpool, United Kingdom

*Product:*	GONAL-f Pen for injection
Active Ingredient:	Follitropin alfa 625IU/mL equivalent to 45.5mcg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers:	Merck Serono SA, Aubonne, Switzerland Merck Serono SpA, Bari, Italy

*Product:*	Panadol Rapid Soluble
Active Ingredient:	Paracetamol 500mg
Dosage Form:	Soluble tablet
New Zealand Sponsor:	Haleon New Zealand ULC
Manufacturers:	Haleon Ireland Dungarvan Limited, Dungarvan, Ireland Olic (Thailand) Limited, Ayutthaya, Thailand

Dated this 26th day of September 2025.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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