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: | Darunavir Sandoz |
Active Ingredient: | Darunavir 600mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Remedica Limited, Limassol, Cyprus |
Product: | Darunavir Sandoz |
Active Ingredient: | Darunavir 800mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Remedica Limited, Limassol, Cyprus |
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 SA, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
Note: | The application received 2 March 2020 for active ingredient method of manufacture changes. |
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 SA, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
Note: | The application received 3 March 2020 for test methods and specifications changes. |
Product: | Humira (20mg/0.4mL) |
Active Ingredient: | Adalimumab 50mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | AbbVie Limited |
Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
Product: | Humira (20mg/0.2mL) |
Active Ingredient: | Adalimumab 100mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | AbbVie Limited |
Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
Product: | Humira (40mg/0.8mL) |
Active Ingredient: | Adalimumab 50mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | AbbVie Limited |
Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
Product: | Humira (40mg/0.8mL Pen) |
Active Ingredient: | Adalimumab 50mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | AbbVie Limited |
Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Aesica Queenborough Limited, Queenborough, United Kingdom Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
Product: | Humira (40mg/0.4mL) |
Active Ingredient: | Adalimumab 100mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | AbbVie Limited |
Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
Product: | Humira (80mg/0.8mL) |
Active Ingredient: | Adalimumab 100mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | AbbVie Limited |
Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
Product: | Humira (40mg/0.4mL Pen) |
Active Ingredient: | Adalimumab 100mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | AbbVie Limited |
Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
Product: | Humira (80mg/0.8mL Pen) |
Active Ingredient: | Adalimumab 100mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | AbbVie Limited |
Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
Product: | Idacio (Syringe and Pen) |
Active Ingredient: | Adalimumab 50mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
Manufacturer: | Merck Serono SpA, Bari, Italy |
Product: | Idacio (Vial) |
Active Ingredient: | Adalimumab 50mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
Manufacturer: | Merck Serono SA, Aubonne, Switzerland |
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, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France GlaxoSmithKline Biologicals SA, Wavre, Belgium |
Note: | The application received 2 March 2020 for active ingredient method of manufacture changes. |
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, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France GlaxoSmithKline Biologicals SA, Wavre, Belgium |
Note: | The application received 3 March 2020 for test methods and specifications changes. |
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, Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
Note: | The application received 2 March 2020 for active ingredient method of manufacture changes. |
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, Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
Note: | The application received 3 March 2020 for test methods and specifications changes. |
Product: | Kogenate FS |
Active Ingredient: | Octocog alfa 250IU |
Dosage Form: | Powder for injection with diluent |
New Zealand Sponsor: | Bayer New Zealand Limited |
Manufacturer: | Bayer Healthcare LLC, California, United States of America |
Product: | Kogenate FS |
Active Ingredient: | Octocog alfa 500IU |
Dosage Form: | Powder for injection with diluent |
New Zealand Sponsor: | Bayer New Zealand Limited |
Manufacturer: | Bayer Healthcare LLC, California, United States of America |
Product: | Kogenate FS |
Active Ingredient: | Octocog alfa 1000IU |
Dosage Form: | Powder for injection with diluent |
New Zealand Sponsor: | Bayer New Zealand Limited |
Manufacturer: | Bayer Healthcare LLC, California, United States of America |
Product: | Kogenate FS |
Active Ingredient: | Octocog alfa 2000IU |
Dosage Form: | Powder for injection with diluent |
New Zealand Sponsor: | Bayer New Zealand Limited |
Manufacturer: | Bayer Healthcare LLC, California, United States of America |
Product: | Kogenate FS |
Active Ingredient: | Octocog alfa 3000IU |
Dosage Form: | Powder for injection with diluent |
New Zealand Sponsor: | Bayer New Zealand Limited |
Manufacturer: | Bayer Healthcare LLC, California, United States of America |
Product: | Tagrisso |
Active Ingredient: | Osimertinib mesilate 47.7mg equivalent to osimertinib 40mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AstraZeneca Limited |
Manufacturer: | AstraZeneca AB, Sodertalje, Sweden |
Product: | Tagrisso |
Active Ingredient: | Osimertinib mesilate 95.4mg equivalent to osimertinib 80mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AstraZeneca Limited |
Manufacturer: | AstraZeneca AB, Sodertalje, Sweden |
Product: | Xolair (75mg/0.5mL) |
Active Ingredient: | Omalizumab 150mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
Product: | Xolair (150mg/mL) |
Active Ingredient: | Omalizumab 150mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
Dated this 10th day of May 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).