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: Saizen 1.33
Active Ingredient: Somatropin 1.33mg equivalent to 4IU
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Industria Farmaceutica Serono SpA, Bari, Italy
Laboratoires Serono SA, Aubonne, Switzerland
Product: Saizen 3.33
Active Ingredient: Somatropin 3.33mg equivalent to 10IU
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Laboratoires Serono SA, Aubonne, Switzerland
Product: Saizen 8
Active Ingredient: Somatropin 8mg equivalent to 24IU
Dosage Form: Multidose vial Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Ares Tradind SA, Manati, Puerto Rico
Industria Farmaceutica Serono SpA, Bari, Italy
Laboratoire Aguettant, Chantecaille, Champagne, France
Laboratoires Serono SA, Aubonne, Switzerland
Dated this 20th day of October 2003.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the
6th day of July 2001).