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:*	Bactol Blue
Active Ingredient:	Ethanol 62.58%w/w equivalent to absolute ethanol 70%v/v
Dosage Form:	Topical gel
New Zealand Sponsor:	Whiteley Corporation (NZ)
Manufacturer:	Felton Grimwade & Bosisto’s Pty Limited, Melbourne, Australia

*Product:*	Entecavir
Active Ingredient:	Entecavir monohydrate 0.533mg equivalent to entecavir 0.50mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	PLIVA Croatia Limited., Zagreb, Croatia

*Product:*	Entecavir
Active Ingredient:	Entecavir monohydrate 1.065mg equivalent to entecavir 1mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	PLIVA Croatia Limited., Zagreb, Croatia

*Product:*	Erlotinib Dr.Reddy’s
Active Ingredient:	Erlotinib hydrochloride 27.317mg equivalent to erlotinib 25mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Dr Reddy’s New Zealand Limited
Manufacturer:	Dr Reddy’s Laboratories Limited, Visakhapatnam, India

*Product:*	Erlotinib Dr.Reddy’s
Active Ingredient:	Erlotinib hydrochloride 109.267mg equivalent to erlotinib 100mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Dr Reddy’s New Zealand Limited
Manufacturer:	Dr Reddy’s Laboratories Limited, Visakhapatnam, India

*Product:*	Erlotinib Dr.Reddy’s
Active Ingredient:	Erlotinib hydrochloride 163.9mg equivalent to erlotinib 150mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Dr Reddy’s New Zealand Limited
Manufacturer:	Dr Reddy’s Laboratories Limited, Visakhapatnam, India

*Product:*	Fasenra Pen
Active Ingredient:	Benralizumab 30mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	AstraZeneca Limited
Manufacturers:	AstraZeneca Pharmaceuticals LP,Maryland, United States of America Catalent Indiana LLC, Indiana, United States of America

Dated this 9th day of August 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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