Medicines Distribution Consent




4356 NEW ZEALAND GAZETTE No. 166

Manufacturer(s):
Mentholatum Australasia Pty Limited, Scoresby, Victoria, Australia

Product:
Losec IV

Active Ingredient(s):
Omeprazole sodium 42.6mg equivalent to 40mg Omeprazole

Dosage Form:
Powder for infusion

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer(s):
AstraZeneca AB, Södertälje, Sweden

Product:
Onectyl

Active Ingredient(s):
Vinorelbine tartrate 13.85mg/mL equivalent to 10mg/mL vinorelbine

Dosage Form:
Solution for injection

New Zealand Sponsor:
Asta Medica Australasia Pty Limited

Manufacturer(s):
Pierre Fabre Medicament Production, Etablissement Aquitaine Pharm International, Idron, France

Dated this 6th day of December 2000.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

g99181

Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:

Schedule

Product:
Aropax

Active Ingredient(s):
Paroxetine hydrochloride 24.9mg equiv to 20mg Paroxetine

Dosage Form:
Film coated tablet

New Zealand Sponsor:
SmithKline Beecham (NZ) Limited

Manufacturer(s):
Les Laboratoires Beecham, Mayenne, France
SmithKline Beecham Pharmaceuticals Limited, Magpie Wood, Manor Royal, Crawley, Sussex, England

Product:
Foradil

Active Ingredient(s):
Eformoterol fumarate 12µg

Dosage Form:
Powder filled inhalation capsule

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Novartis Pharma Stein AG/SA, Stein, Switzerland
Novartis Pharmaceuticals UK Limited, Horsham, West Sussex, United Kingdom

Product:
Fosamax

Active Ingredient(s):
Alendronate sodium 13.05mg equivalent to 10mg Alendronic acid

Dosage Form:
Tablet

New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited

Manufacturer(s):
Merck Manufacturing Division of Merck and Co., Bo. Sabana Hoyos, Arecibo, Puerto Rico
Merck Sharp & Dohme SpA., Pavia, Italy

Product:
Fosamax

Active Ingredient(s):
Alendronate sodium 6.53mg equivalent to 5mg alendronic acid

Dosage Form:
Tablet

New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited

Manufacturer(s):
Merck Sharp & Dohme SpA., Pavia, Italy

Product:
Ultravist 240

Active Ingredient(s):
Iopromide 498.72mg/mL equivalent to 240mg iodine

Dosage Form:
Solution for injection

New Zealand Sponsor:
Schering (NZ) Limited

Manufacturer(s):
Schering AG, Wedding Plant, Berlin, Germany

Dated this 6th day of December 2000.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2000, No 166


Gazette.govt.nz PDF NZ Gazette 2000, No 166





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
6 December 2000
Medicines Act 1981, New Medicine, Losec IV, Onectyl, Omeprazole, Vinorelbine
  • G. R. BOYD, Chief Advisor, Safety and Regulation

🏥 Consent to the Distribution of Changed Medicines

🏥 Health & Social Welfare
6 December 2000
Medicines Act 1981, Changed Medicine, Aropax, Foradil, Fosamax, Ultravist 240, Paroxetine, Eformoterol, Alendronate, Iopromide
  • G. R. BOYD, Chief Advisor, Safety and Regulation