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:*	Kalydeco
Active Ingredient:	Ivacaftor 25mg
Dosage Form:	Oral granules
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers:	Almac Pharma Services Limited, Craigavon, United Kingdom Halo Pharmaceutical Inc, New Jersey, United States of America Catalent Greenville Inc, North Carolina, United States of America

*Product:*	Kalydeco
Active Ingredient:	Ivacaftor 50mg
Dosage Form:	Oral granules
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers:	Almac Pharma Services Limited, Craigavon, United Kingdom Halo Pharmaceutical Inc, New Jersey, United States of America Catalent Greenville Inc, North Carolina, United States of America

*Product:*	Kalydeco
Active Ingredient:	Ivacaftor 75mg
Dosage Form:	Oral granules
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers:	Almac Pharma Services Limited, Craigavon, United Kingdom Halo Pharmaceutical Inc, New Jersey, United States of America Catalent Greenville Inc, North Carolina, United States of America

*Product:*	Kalydeco
Active Ingredient:	Ivacaftor 150mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers:	Aesica Queenborough Limited, Queenborough, United Kingdom Patheon Pharmaceuticals Inc, Ohio, United States of America

*Product:*	Nimenrix
Active Ingredients:	Neisseria meningitidis Group A polysaccharide, tetanus toxoid conjugate 5mcg Neisseria meningitidis Group C polysaccharide, tetanus toxoid conjugate 5mcg Neisseria meningitidis Group W135 polysaccharide, tetanus toxoid conjugate 5mcg Neisseria meningitidis Group Y polysaccharide, tetanus toxoid conjugate 5mcg
Dosage Form:	Powder for injection with diluent
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturers:	GlaxoSmithKline Biologicals SA (Wave Nord), Wavre, Belgium Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium

*Product:*	Xolair (75mg/0.5mL)
Active Ingredient:	Omalizumab 150mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

*Product:*	Xolair (150mg/1mL)
Active Ingredient:	Omalizumab 150mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Dated this 22nd day of March 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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