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: Accuretic
Active Ingredients: Hydrochlorothiazide 12.5mg
Quinapril hydrochloride 10.832mg equivalent to quinapril free base 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
   
Product: Accuretic
Active Ingredients: Hydrochlorothiazide 12.5mg
Quinapril hydrochloride 21.664mg equivalent to quinapril free base 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
   
Product: Boostrix-IPV
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 2.5mcg
Pertussis filamentous haemagglutinin 8mcg
Pertussis toxoid, adsorbed 8mcg
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: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
   
Product: Instillagel Lido
Active Ingredient: Lidocaine hydrochloride 20mg/g
Dosage Form: Topical gel
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Klosterfrau Berlin GmbH, Berlin, Germany
   
Product: Toujeo
Active Ingredient: Insulin glargine 300IU/mL equivalent to 10.91mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturer: Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany


Dated this 9th day of February 2021.

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