Notice Type
Departmental
Notice Title

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:

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).