Notice Type
Departmental
Notice Title

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: ADT Booster
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Tetanus toxoid, adsorbed 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: Seqirus (NZ) Limited
Manufacturer: AJ Vaccines A/S, Copenhagen, Denmark
   
Product: NeutraFluor 5000 Sensitive
Active Ingredients: Potassium nitrate 5%w/w
Sodium fluoride 1.105%w/w equivalent to fluoride 5000ppm
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturer: Colgate-Palmolive Company, Tennessee, United States of America
   
Product: Rapifen
Active Ingredient: Alfentanil hydrochloride 0.5435mg/mL equivalent to alfentanil 0.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Seed Pharma Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
GlaxoSmithKline Manufacturing SpA, Parma, Italy


Dated this 28th day of August 2020.

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