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: | Hemlibra |
| Active Ingredient: | Emicizumab 30mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan Samsung Biologics Co Limited, Incheon, South Korea |
| Product: | Hemlibra (60mg/0.4mL) |
| Active Ingredient: | Emicizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan Samsung Biologics Co Limited, Incheon, South Korea |
| Product: | Hemlibra (105mg/0.7mL) |
| Active Ingredient: | Emicizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan Samsung Biologics Co Limited, Incheon, South Korea |
| Product: | Hemlibra (150mg/1mL) |
| Active Ingredient: | Emicizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan Samsung Biologics Co Limited, Incheon, South Korea |
| Product: | Hiberix |
| 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 SA, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
| Product: | Infanrix-hexa |
| Component one: | |
| Active Ingredients: | Diphtheria toxoid, adsorbed 30IU Pertactin 8mcg Hepatitis B surface antigen, recombinant 10mcg 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, Wavre, Belgium GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
| Product: | Infanrix-IPV+Hib |
| Component one: | |
| Active Ingredients: | Detoxified pertussis toxin 25mcg Diphtheria toxoid, adsorbed 30IU Pertactin 8mcg Pertussis filamentous haemagglutinin 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, Wavre, Belgium GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
| Product: | Questran Lite |
| Active Ingredient: | Colestyramine 0.851g/g |
| Dosage Form: | Powder for oral suspension |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aspen Pharma Pty Limited, Melbourne, Australia |
| Product: | Saxenda |
| Active Ingredient: | Liraglutide 6mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
| Manufacturer: | Novo Nordisk A/S, Copenhagen, Denmark |
| Product: | Twinrix |
| Active Ingredients: | Hepatitis A vaccine 720EU/mL Hepatitis B surface antigen, recombinant 20mcg/mL |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium |
Dated this 2nd day of August 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).