Notice Title

Consent to the Distribution of New Medicines

Publication Date
8 Sep 2022

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2022-go3790
Title
View PDF
File Type and Size
PDF (35 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: Adacel Polio
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 3mcg
Pertussis filamentous haemagglutinin 5mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 2.5mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Sanofi Pasteur Limited, Toronto, Canada
   
Product: Bepanthen tattoo
Active Ingredient: Dexpanthenol 50mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany
   
Product: Trazimera
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Belgium NV, Puurs, Belgium
   
Product: Trazimera
Active Ingredient: Trastuzumab 440mg
Dosage Form: Powder for infusion concentrate with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Belgium NV, Puurs, Belgium


Dated this 5th day of September 2022.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).