Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Depo-Provera
Active Ingredient: Medroxyprogesterone acetate 150mg/mL
Dosage Form: Injection (depot)
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pharmacia NV/SA, Rijksweg 12, Puurs, Belgium
Product: Infanrix
Active Ingredients: Detoxified pertussis toxin 25Ág
Diphtheria toxoid, adsorbed 30IU
Pertactin 8Ág
Pertussis filamentous haemagglutinin 25Ág
Tetanus toxoid, adsorbed 40IU
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals, Rixensart, Belgium
Sachsisches Serumwerk Dresden, Dresden, Germany
Product: Infanrix-HepB
Active Ingredients: Detoxified pertussis toxin 50Ág/mL
Diphtheria toxoid, adsorbed 60IU/mL
Hepatitis B surface antigen, recombinant 20Ág/mL
Pertactin 16Ág/mL
Pertussis filamentous haemagglutinin 50Ág/mL
Tetanus toxoid 80IU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Product: Infanrix-hexa (Combination Product)
Component One:
Active Ingredients: Diphtheria toxoid, adsorbed 30IU/dose
Hepatitis B surface antigen, recombinant 10Ág/dose
Pertactin 8Ág/dose
Pertussis filamentous haemagglutinin 25Ág/dose
Pertussis toxoid, adsorbed 25Ág/dose
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 40IU/dose
Dosage Form: Suspension for injection
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Component Two:
Active Ingredient: Haemophilus influenzae type b vaccine 10Ág/dose
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Product: Infanrix-Hib vaccine (Combination Product)
Component One:
Active Ingredients: Detoxified pertussis toxin 25Ág
Diphtheria toxoid, adsorbed 30IU
Pertactin 8Ág
Pertussis filamentous haemagglutinin 25Ág
Tetanus toxoid 40IU
Dosage Form: Suspension for injection
Component Two:
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10Ág
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Product: Infanrix-IPV (notification received 4 August 2003)
Active Ingredients: Detoxified pertussis toxin 50Ág/mL
Diphtheria toxoid, adsorbed 60IU/mL
Pertactin 16Ág/mL
Pertussis filamentous haemagglutinin 50Ág/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, Rixensart, Belgium
Product: Infanrix-IPV (notification received 6 August 2003)
Active Ingredients: Detoxified pertussis toxin 50Ág/mL
Diphtheria toxoid, adsorbed 60IU/mL
Pertactin 16Ág/mL
Pertussis filamentous haemagglutinin 50Ág/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, Rixensart, Belgium
Product: Infanrix-IPV-Hib (Combination Product) (notification received 4 August 2003)
Component One:
Active Ingredients: Detoxified pertussis toxin 50Ág/mL
Diphtheria toxoid, adsorbed 60IU/mL
Pertactin 16Ág/mL
Pertussis filamentous haemagglutinin 50Ág/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
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Component Two:
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 20Ág/mL
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Product: Infanrix-IPV-Hib (Combination Product) (notification received 6 August 2003)
Component One:
Active Ingredients: Detoxified pertussis toxin 50Ág/mL
Diphtheria toxoid, adsorbed 60IU/mL
Pertactin 16Ág/mL
Pertussis filamentous haemagglutinin 50Ág/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
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Component Two:
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 20Ág/mL
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Product: Infanrix-penta
Active Ingredients: Diphtheria toxoid, adsorbed 30IU/dose
Hepatitis B surface antigen, recombinant 10Ág/dose
Pertactin 8Ág/dose
Pertussis filamentous haemagglutinin 25Ág/dose
Pertussis toxoid, adsorbed 25Ág/dose
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 40IU/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Product: Mencevax ACWY vaccine
Active Ingredients: Neisseria meningitidis, group A 50Ág
Neisseria meningitidis, Group C 50Ág
Neisseria meningitidis, group W135 50Ág
Neisseria meningitidis, group Y 50Ág
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Product: Provera HD
Active Ingredient: Medroxyprogesterone acetate 100mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pharmacia Italia SpA, Marino del Tronto, Ascoli Piceno, Italy
Product: Provera HD
Active Ingredient: Medroxyprogesterone acetate 200mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pharmacia Italia SpA, Marino del Tronto, Ascoli Piceno, Italy
Product: Provera
Active Ingredient: Medroxyprogesterone acetate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pharmacia Italia SpA, Marino del Tronto, Ascoli Piceno, Italy
Pharmacia NV/SA, Puurs, Belgium
Product: Provera
Active Ingredient: Medroxyprogesterone acetate 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pharmacia Italia SpA, Marino del Tronto, Ascoli Piceno, Italy
Pharmacia NV/SA, Puurs, Belgium
Product: Provera
Active Ingredient: Medroxyprogesterone acetate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pharmacia Italia SpA, Marino del Tronto, Ascoli Piceno, Italy
Pharmacia NV/SA, Puurs, Belgium
Product: Tamiflu
Active Ingredient: Oseltamivir phosphate 98.5mg equivalent to 75mg oseltamivir
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Dated this 2nd day of February 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the
6th day of July 2001).