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:*	Cetrotide
Active Ingredient:	Cetrorelix acetate 0.26mg equivalent to cetrorelix 0.25mg
Dosage Form:	Powder for injection with diluent
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers:	Baxter Oncology GmbH, Westfalen, Germany Fareva Pau SAS, Idron, France

*Product:*	Duofilm
Active Ingredients:	Lactic acid 16.7%w/w Salicylic acid 16.7%w/w
Dosage Form:	Topical solution
New Zealand Sponsor:	Nice-Pak Products (NZ) Limited
Manufacturers:	Stiefel Laboratories (Ireland) Limited, Sligo, Ireland Delpharm Bladel B.V., Bladel, Netherlands

*Product:*	Eltroxin
Active Ingredient:	Levothyroxine sodium pentahydrate 111.26mcg equivalent to levothyroxine sodium 100mcg
Dosage Form:	Tablet
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Aspen Bad Oldesloe GmbH, Bad Oldesloe, Germany

*Product:*	Rozlytrek
Active Ingredient:	Entrectinib 100mg
Dosage Form:	Capsule
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturer:	Mayne Pharma Inc, North Carolina, United States of America

*Product:*	Rozlytrek
Active Ingredient:	Entrectinib 200mg
Dosage Form:	Capsule
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturer:	Mayne Pharma Inc, North Carolina, United States of America

Dated this 19th day of June 2023.

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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