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:*	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
Manufacturer:	GlaxoSmithKline Vaccines SRL, Sovicille, Italy

*Product:*	Clopidogrel Multichem
Active Ingredient:	Clopidogrel besilate 112.1mg equivalent to clopidogrel 75mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Multichem NZ Limited
Manufacturers:	Pharmathen SA, Pallini, Greece Boehringer Ingelheim Hellas Single Member S.A., Koropi, Greece Pharmathen International SA, Rodopi, Greece

*Product:*	Fragmin
Active Ingredient:	Dalteparin sodium 10000IU/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturers:	Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Pfizer Manufacturing Belgium NV, Puurs, Belgium

*Product:*	Fragmin
Active Ingredient:	Dalteparin sodium 12500IU/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturers:	Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Pfizer Manufacturing Belgium NV, Puurs, Belgium Catalent France Limoges SAS, Limoges, France

*Product:*	Fragmin
Active Ingredient:	Dalteparin sodium 25000IU/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturers:	Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Pfizer Manufacturing Belgium NV, Puurs, Belgium Catalent France Limoges SAS, Limoges, France

*Product:*	Gazyva
Active Ingredient:	Obinutuzumab 1000mg
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturer:	Roche Diagnostics GmbH, Mannheim, Germany

*Product:*	Keytruda
Active Ingredient:	Pembrolizumab 25mg/mL
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	Merck Sharp & Dohme (New Zealand) Limited
Manufacturer:	MSD International GmbH t/a MSD Ireland (Carlow), Carlow, Ireland

Dated this 19th day of July 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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