✨ Medicines Notices
NEW ZEALAND GAZETTE, No. 183
3 NOVEMBER 2005
Consent to the Distribution of a Changed Medicine
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).
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Provisional Consent to the Distribution of a New Medicine
Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Mestinon
Active Ingredient: Pyridostigmine bromide 61.2mg equivalent to 60mg Pyridostigmine
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Valeant Canada Limited, Montreal, Quebec, Canada
Note: This consent is valid for two years from the date of publication of this notice.
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).
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2005, No 183
Gazette.govt.nz —
NZ Gazette 2005, No 183
✨ LLM interpretation of page content
🏥
Consent to the Distribution of a Changed Medicine
(continued from previous page)
🏥 Health & Social Welfare28 October 2005
Medicines Act, Changed Medicine, Distribution Consent, Pharmaceuticals
- DON MATHESON, Deputy Director-General, Public Health
🏥 Provisional Consent to the Distribution of a New Medicine
🏥 Health & Social Welfare28 October 2005
Medicines Act, New Medicine, Provisional Consent, Pharmaceuticals
- DON MATHESON, Deputy Director-General, Public Health