✨ Medicine Distribution Consents




7 APRIL 2005 NEW ZEALAND GAZETTE, No. 62

1551

Product: Levemir Flexpen
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Brennum Park, Hillerod, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark

Product: Levemir Innolet
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Brennum Park, Hillerod, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark

Product: Levemir Penfill
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Brennum Park, Hillerod, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark

Dated this 2nd day of April 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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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: Emend Tri-pack
Active Ingredient: Aprepitant 80mg
Dosage Form: Capsule
Active Ingredient Aprepitant 125mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America

Product: Emend
Active Ingredient: Aprepitant 125mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America

Product: Emend
Active Ingredient: Aprepitant 80mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America

Dated this 2nd day of April 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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Renewal of 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: Aspartate - Glutamate
Active Ingredients: Monosodium glutamate 228mmol/L
Sodium aspartate 228mmol/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Point Chevalier, Auckland

Note: This consent is valid for two years from 26 April 2005.



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2005, No 62


Gazette.govt.nz PDF NZ Gazette 2005, No 62





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
2 April 2005
Medicines Act, New medicines, Distribution consent, Insulin detemir, Levemir
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Consent to the Distribution of a Changed Medicine

πŸ₯ Health & Social Welfare
2 April 2005
Medicines Act, Changed medicine, Distribution consent, Aprepitant, Emend
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
2 April 2005
Medicines Act, Provisional consent, New medicine, Monosodium glutamate, Sodium aspartate
  • DON MATHESON, Deputy Director-General, Public Health