✨ Consent to Distribution of New Medicines




NEW ZEALAND GAZETTE

No. 89

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of
the new medicines set out in the Schedule hereto:

Schedule

Product:
Extraneal

Active Ingredients:

  • Calcium chloride dihydrate 257mg/L
  • Icodextrin 75g/L
  • Magnesium chloride hexahydrate 51mg/L
  • Sodium chloride 5.4g/L
  • Sodium lactate 4.5g/L

Dosage Form:
Dialysis solution

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer:
Baxter Healthcare Pty Limited, Old Toongabbie, New South Wales, Australia

Product:
Fentanyl-Hameln

Active Ingredient:
Fentanyl citrate 50Β΅g/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Multichem NZ Limited

Manufacturer:
Hameln Pharmaceuticals GmbH, Hameln, Germany

Product:
Gadovist

Active Ingredient:
Gadobutrol 302.36mg/mL equivalent to 0.5mmol/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Schering (NZ) Limited

Manufacturer:
Schering AG, Charlottenburg, Berlin, Germany

Product:
Gadovist

Active Ingredient:
Gadobutrol 604.72mg equivalent to 1mmol/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Schering (NZ) Limited

Manufacturer:
Schering AG, Charlottenburg, Berlin, Germany

Product:
Kaletra

Active Ingredients:

  • Lopinavir 133.3mg
  • Ritonavir 33.3mg

Dosage Form:
Soft gelatin capsule

New Zealand Sponsor:
Abbott Laboratories (NZ) Limited

Manufacturer:
Cardinal Health Oral Technologies, St Petersburg, Florida, United States of America

Product:
Kaletra

Active Ingredients:

  • Lopinavir 80mg/mL
  • Ritonavir 20mg/mL

Dosage Form:
Oral solution

New Zealand Sponsor:
Abbott Laboratories (NZ) Limited

Manufacturer:
Abbott Laboratories Limited, Queenborough, Kent, United Kingdom

Product:
Viracept

Active Ingredient:
Nelfinavir mesilate 58.5mg/g equivalent 50mg/g nelfinavir free base

Dosage Form:
Powder for oral suspension

New Zealand Sponsor:
Roche Products (New Zealand) Limited

Manufacturer:
F Hoffmann-La Roche Ltd, Basel, Switzerland

Product:
Viracept

Active Ingredient:
Nelfinavir mesilate 292.25mg equivalent 250mg nelfinavir free base

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Roche Products (New Zealand) Limited

Manufacturers:

  • F Hoffmann-La Roche Ltd, Basel, Switzerland
  • Roche Farma S.A., Leganes (Madrid), Spain

Dated this 24th day of July 2003.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2003, No 89


Gazette.govt.nz PDF NZ Gazette 2003, No 89





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
24 July 2003
Medicines, Consent, Distribution, Dialysis solution, Solution for injection, Soft gelatin capsule, Oral solution, Powder for oral suspension, Film coated tablet
  • G. R. Boyd, Chief Advisor, Safety and Regulation