Medicinal Product Approvals




12 DECEMBER

NEW ZEALAND GAZETTE

4489

Product:
Lamictal
Active Ingredient:
Lamotrigine 25mg
Dosage Form:
Chewable/dispersible tablet
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturers:
Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom
Glaxo Wellcome Operations, Temple Hill, Dartford, Kent, United Kingdom
GlaxoSmithKline Australia Pty Limited, Boronia, Victoria, Australia

Product:
Lamictal
Active Ingredient:
Lamotrigine 50mg
Dosage Form:
Chewable/dispersible tablet
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturers:
Glaxo Wellcome Operations, Temple Hill, Dartford, Kent, United Kingdom
GlaxoSmithKline Australia Pty Limited, Boronia, Victoria, Australia

Product:
Losec MUPS
Active Ingredient:
Omeprazole magnesium 10.3mg equivalent to 10mg omeprazole
Dosage Form:
Film coated tablet
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer:
AstraZeneca AB, Sodertalje, Sweden

Product:
Losec MUPS
Active Ingredient:
Omeprazole magnesium 20.6mg equivalent to 20mg omeprazole
Dosage Form:
Film coated tablet
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer:
AstraZeneca AB, Sodertalje, Sweden

Product:
NovoNorm
Active Ingredient:
Repaglinide 0.5mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany

Product:
NovoNorm
Active Ingredient:
Repaglinide 1mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany

Product:
NovoNorm
Active Ingredient:
Repaglinide 2mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany

Product:
Rocaltrol
Active Ingredient:
Calcitriol 0.25µg
Dosage Form:
Liquid filled capsule
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturers:
F Hoffmann-La Roche AG, Basel, Switzerland
R P Scherer & Co. KG., Eberbach/Baden, Germany

Product:
Rocaltrol
Active Ingredient:
Calcitriol 0.5µg
Dosage Form:
Liquid filled capsule
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturers:
F Hoffmann-La Roche AG, Basel, Switzerland
R P Scherer & Co. KG., Eberbach/Baden, Germany

Product:
Rocaltrol
Active Ingredient:
Calcitriol 1µg/mL
Dosage Form:
Oral solution
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer:
Roche Prodotti SpA, Segrate, Milan, Italy

Dated this 3rd day of December 2002.

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 2002, No 178


Gazette.govt.nz PDF NZ Gazette 2002, No 178





✨ LLM interpretation of page content

🏥 Consent to the Distribution of Changed Medicines (continued from previous page)

🏥 Health & Social Welfare
3 December 2002
Medicines, Distribution, Lamictal, Lamotrigine, Losec MUPS, Omeprazole, NovoNorm, Repaglinide, Rocaltrol, Calcitriol
  • G. R. Boyd, Chief Advisor, Safety and Regulation