Notice Title

Consent to the Distribution of New Medicines

Publication Date
22 Jun 2023

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2023-go2589
Title
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File Type and Size
PDF (36 KB)

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).