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:
| 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 SAS (France), Saint-Amand-Les-Eaux, France |
| 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, adsorbed 20IU |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA (Wave Nord), Rixensart, Belgium GlaxoSmithKline Biologicals SAS (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 |
| Manufacturer: | GlaxoSmithKline Biologicals SAS (France), Saint-Amand-Les-Eaux, France |
| Product: | Infanrix-hexa |
| Component 1: | |
| 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 2: | |
| Active Ingredient: | Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA (Wave Nord), Rue Flemming, Belgium GlaxoSmithKline Biologicals SAS (France), Saint-Amand-Les-Eaux, France |
| 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 |
| Manufacturer: | GlaxoSmithKline Biologicals SAS (France), Saint-Amand-Les-Eaux, France |
| Product: | Infanrix-IPV+Hib |
| Component 1: | |
| 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 2: | |
| Active Ingredient: | Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA (Wave Nord), Rue Flemming, Belgium GlaxoSmithKline Biologicals SAS (France), Saint-Amand-Les-Eaux, France |
| Product: | Skyrizi (360mg/2.4mL) |
| Active Ingredient: | Risankizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | Patheon Italia S.p.A,Milan, Italy |
| Product: | Skyrizi |
| Active Ingredient: | Risankizumab 60mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | Patheon Italia S.p.A, Milan, Italy |
Dated this 30th day of October 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).