Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:
Schedule
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 1.2mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Indication Change: Single dose treatment
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 2.4mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Indication Change: Single dose treatment
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 4.8mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Indication change: Single dose treatment
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 1.2mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Indications/Dosage Change: Dosage regimen for intervention in frequently bleeding patients
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 2.4mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Indications/Dosage Change: Dosage regimen for intervention in frequently bleeding patients
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 4.8mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Indications/Dosage Change: Dosage regimen for intervention in frequently bleeding patients
Dated this 10th day of August 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).