✨ Medicines Distribution Consent




15 DECEMBER 2005

NEW ZEALAND GAZETTE, No. 207

5271

Product:
Eloxatin

Active Ingredient:
Oxaliplatin 50mg

Dosage Form:
Powder for injection

New Zealand Sponsor:
Aventis Pharma Limited

Manufacturer:
Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Laboratoires Thissen SA, Braine-L’Alleud, Belgium

Product:
NovoMix 30 Flexpen

Active Ingredient:
Insulin aspart 100IU/mL

Dosage Form:
Suspension for injection

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark

Product:
NovoMix 30 Penfill

Active Ingredient:
Insulin aspart 100IU/mL

Dosage Form:
Suspension for injection

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark

Product:
NovoRapid FlexPen

Active Ingredient:
Insulin aspart 100IU/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturers:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Production S.A.S, Chartres Cedex, France

Product:
NovoRapid Penfill

Active Ingredient:
Insulin aspart 100U/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturers:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Production S.A.S, Chartres Cedex, France

Product:
NovoRapid

Active Ingredient:
Insulin aspart 100U/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturers:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutical Industries Inc., North Carolina, United States of America

Dated this 8th day of December 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 New Medicines

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 medicines set out in the Schedule hereto:

Schedule

Product:
Viramune

Active Ingredient:
Nevirapine 200mg

Dosage Form:
Tablet

New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited

Manufacturers:
Boehringer Ingelheim Pharmaceuticals Inc, Danbury, Connecticut, United States of America
Boehringer Ingelheim Roxane Inc, Columbus, Ohio, United States of America

Note: This consent is valid for two years from 4 December 2005.

Product:
HyperHep B

Active Ingredient:
Hepatitis B immunoglobulin, human 220IU/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Bayer New Zealand Limited

Manufacturer:
Talecris Biotherapeutics, Inc., Clayton, North Carolina, United States of America

Note: This consent is valid for two years from 13 December 2005.

Product:
Fabrazyme

Active Ingredient:
Agalsidase beta - rch 35mg

Dosage Form:
Powder for infusion

New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics

Manufacturer:
Genzyme Corporation, Allston, Massachusetts, United States of America



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2005, No 207


Gazette.govt.nz PDF NZ Gazette 2005, No 207





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Changed Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
8 December 2005
Medicines Act, Changed Medicines, Distribution, Eloxatin, Oxaliplatin, NovoMix, NovoRapid
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Renewal of Provisional Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines Act, Provisional Consent, Distribution, Viramune, Nevirapine, HyperHep B, Hepatitis B immunoglobulin, Fabrazyme, Agalsidase beta