Gazette.govt.nzPursuant 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: | 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 |
| Manufacturer: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
| Product: | Boostrix-IPV |
| Active Ingredients: | Diphtheria toxoid, adsorbed 2.5Lf U 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 5Lf U |
| 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: | Infanrix |
| Active Ingredients: | Diphtheria toxoid, adsorbed 30IU Pertactin 8mcg Pertussis filamentous haemagglutinin 25mcg Pertussis toxoid, adsorbed 25mcg Tetanus toxoid, adsorbed 40IU |
| Dosage Form: | Vaccine suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
| Product: | Infanrix-hexa |
| Component one: | |
| Active Ingredients: | Diphtheria toxoid, adsorbed 30IU Hepatitis B surface antigen, recombinant 10mcg Pertactin 8mcg Pertussis filamentous haemagglutinin 25mcg Pertussis toxoid, adsorbed 25mcg Polio virus type 1 40DAgU Polio virus type 2 8DAgU Polio virus type 3 32DAgU Tetanus toxoid, adsorbed 40IU |
| Dosage Form: | Suspension for injection |
| Component two: | |
| Active Ingredient: | Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France GlaxoSmithKline Biologicals SA, Wavre, Belgium |
| Product: | Infanrix-IPV |
| Active Ingredients: | Diphtheria toxoid, adsorbed 60IU/mL Pertactin 16mcg/mL Pertussis filamentous haemagglutinin 50mcg/mL Pertussis toxoid, adsorbed 50mcg/mL Polio virus type 1 80DAgU/mL Polio virus type 2 16DAgU/mL Polio virus type 3 64DAgU/mL Tetanus toxoid, adsorbed 80IU/mL |
| 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: | Infanrix-IPV+Hib |
| Component one: | |
| Active Ingredients: | Diphtheria toxoid, adsorbed 30IU Pertactin 8mcg Pertussis filamentous haemagglutinin 25mcg Pertussis toxoid, adsorbed 25mcg Polio virus type 1 40DAgU Polio virus type 2 8DAgU Polio virus type 3 32DAgU Tetanus toxoid, adsorbed 40IU |
| Dosage Form: | Suspension for injection |
| Component two: | |
| Active Ingredient: | Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
| Product: | Infanrix-penta |
| Active Ingredients: | Diphtheria toxoid, adsorbed 30IU Hepatitis B surface antigen, recombinant 10mcg Pertactin 8mcg Pertussis filamentous haemagglutinin 25mcg Pertussis toxoid, adsorbed 25mcg Polio virus type 1 40DAgU Polio virus type 2 8DAgU Polio virus type 3 32DAgU Tetanus toxoid, adsorbed 40IU |
| 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: | Optiray 240 |
| Active Ingredient: | Ioversol 51% |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Obex Medical Limited |
| Manufacturer: | Liebel-Flarsheim Canada Inc, Montreal, Canada |
| Product: | Optiray 320 |
| Active Ingredient: | Ioversol 68% |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Obex Medical Limited |
| Manufacturer: | Liebel-Flarsheim Canada Inc, Montreal, Canada |
| Product: | Optiray 350 |
| Active Ingredient: | Ioversol 74% |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Obex Medical Limited |
| Manufacturer: | Liebel-Flarsheim Canada Inc, Montreal, Canada |
| Product: | Optiray 240 (Ultraject) |
| Active Ingredient: | Ioversol 51% |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Obex Medical Limited |
| Manufacturer: | Liebel-Flarsheim Canada Inc, Montreal, Canada |
| Product: | Optiray 300 (Ultraject) |
| Active Ingredient: | Ioversol 64% |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Obex Medical Limited |
| Manufacturer: | Liebel-Flarsheim Canada Inc, Montreal, Canada |
| Product: | Optiray 320 (Ultraject) |
| Active Ingredient: | Ioversol 68% |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Obex Medical Limited |
| Manufacturer: | Liebel-Flarsheim Canada Inc, Montreal, Canada |
| Product: | Optiray 350 (Ultraject) |
| Active Ingredient: | Ioversol 74% |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Obex Medical Limited |
| Manufacturer: | Liebel-Flarsheim Canada Inc, Montreal, Canada |
| Product: | Praluent |
| Active Ingredient: | Alirocumab 75mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand limited |
| Manufacturers: | Sanofi Winthrop Industrie, Le Trait, France Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany Sanofi Pasteur Inc, Pennsylvania, United States of America |
| Product: | Praluent |
| Active Ingredient: | Alirocumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand limited |
| Manufacturers: | Sanofi Winthrop Industrie, Le Trait, France Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany |
Dated this 6th day of April 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).