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: Dysport
Active Ingredient: Clostridium botulinum type A toxin haemagglutinin complex 500U
Dosage Form: Powder for injection
New Zealand Sponsor: New Zealand Medical & Scientific Limited
Manufacturer: Ispen Limited, Clwyd, United Kingdom
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 1.2mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 2.4mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 4.8mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: Rapilysin
Active Ingredient: Reteplase 10U
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
Product: Saizen 1.33
Active Ingredient: Somatropin 1.33mg equivalent to 4IU
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Industria Farmaceutica Serono SpA, di Modugno, Bari, Italy
Laboratoires Serono SA, l’Ouriettaz, Aubonne, Switzerland
Product: Saizen 3.33
Active Ingredient: Somatropin 3.33mg equivalent to 10IU Includes 0.33mg overfill
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Laboratoires Serono SA, l’Ouriettaz, Aubonne, Switzerland
Product: Saizen 8
Active Ingredient: Somatropin 8mg equivalent to 24IU, plus 0.8mg overfill
Dosage Form: Multidose vial powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Industria Farmaceutica Serono SpA, di Modugno, Bari, Italy
Laboratoires Serono SA, l’Ouriettaz, Aubonne, Switzerland
Dated this 2nd day of March 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).