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: Aranesp
Active Ingredient: Darbepoetin alfa 100µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer: Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient: Darbepoetin alfa 15µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer: Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient: Darbepoetin alfa 200µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer: Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient: Darbepoetin alfa 25µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer: Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient: Darbepoetin alfa 40µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer: Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient: Darbepoetin alfa 500µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer: Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient: Darbepoetin alfa 60µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer: Amgen Puerto Rico Inc., Juncos, Puerto Rico
Dated this 28th day of October 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).