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: AdiraMedica Diclofenac Potassium 12.5 Fast
Active Ingredient: Diclofenac potassium 12.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AdiraMedica Pty Limited
Manufacturer: Sunglow Lifescience Private Limited, Kanchipuram, India
   
Product: AdiraMedica Diclofenac Potassium 25 Fast
Active Ingredient: Diclofenac potassium 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AdiraMedica Pty Limited
Manufacturer: Sunglow Lifescience Private Limited, Kanchipuram, India
   
Product: Boostrix
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 2.5mcg
Pertussis filamentous haemagglutinin 8mcg
Pertussis toxoid, adsorbed 8mcg
Tetanus toxoid, adsorbed 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: GlaxoSmithKline Biologicals SA (Wave Nord), Rixensart, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
   
Product: Efudix
Active Ingredient: Fluorouracil 5%
Dosage Form: Topical cream
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturers: Ensign Laboratories Pty Limited, Melbourne, Australia
ICN Polfa Rzeszow SA, Rzeszow, Poland


Dated this 2nd day of October 2023.

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