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: | 4% Articadent DENTAL with Adrenaline (Epinephrine) 1:100,000 |
| Active Ingredients: | Adrenaline acid tartrate 18.2mcg/mL equivalent to adrenaline 10mcg/mL Articaine hydrochloride 40mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Dentsply Sirona (NZ) Limited |
| Manufacturer: | Laboratorios INIBSA, S.A., Barcelona, Spain |
| Product: | Flumazenil |
| Active Ingredient: | Flumazenil 0.1mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Siegfried Hameln GmbH, Hameln, Germany |
| Product: | Hiberix |
| Active Ingredient: | Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
| Product: | Infanrix-hexa |
| Component 1: Active Ingredients: |
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| 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 (France), Saint-Amand-Les-Eaux, France GlaxoSmithKline Biologicals SA, Wavre, Belgium |
| 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 10mcg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
| 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 am Main, Germany Sanofi Pasteur Inc, Pennsylvania, United States of America Genzyme Ireland Limited, Waterford, Ireland |
| 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 am Main, Germany Genzyme Ireland Limited, Old Kilmeadon Road, Waterford, Ireland |
| Product: | Priorix |
| Active Ingredients: | Measles vaccine, Schwarz strain 1000CCID50 Mumps virus, live attenuated, RIT 4385 5012CCID50 Rubella virus, Wistar RA27/3 strain 1000CCID50 |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Fidia Farmaceutici SpA, Abano Terme, Italy Corixia Corporation dba GlaxoSmithKline Vaccines, Pennsylvania, United States of America |
| Product: | Priorix-Tetra |
| Active Ingredients: | Measles vaccine, Schwarz strain 1000CCID50 Mumps virus, live attenuated, RIT 4385 25119CCID50 Rubella virus, Wistar RA27/3 strain 1000CCID50 Varicella vaccine 1995PFU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium |
| Product: | Quadracel |
| Active Ingredients: | Diphtheria toxoid, adsorbed 15Lf U Pertactin 3mcg Pertussis filamentous haemagglutinin 20mcg Pertussis fimbriae 2+3 5mcg Pertussis toxoid, adsorbed 20mcg Polio virus type 1 40DAgU Polio virus type 2 8DAgU Polio virus type 3 32DAgU Tetanus toxoid, adsorbed 5Lf U |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Sanofi Pasteur Limited, Ontario, Canada |
| Product: | RINVOQ |
| Active Ingredient: | Upadacitinib hemihydrate 15.4mg equivalent to upadacitinib 15mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | AbbVie Ireland NL B.V., Sligo, Ireland |
| Product: | Varilrix Vaccine |
| Active Ingredient: | Varicella vaccine 2000PFU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Corixa Corporation dba GlaxoSmithKline Vaccines, Pennsylvania, United States of America Fidia Farmaceutici SpA, Abano Terme, Italy |
Dated this 2nd day of November 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).