Notice Type
Departmental
Notice Title

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: Cozaar
Active Ingredient: Losartan potassium 12.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme UK Limted, Cramlington, Northumberland, United Kingdom
Product: Cozaar
Active Ingredient: Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Product: Lamictal
Active Ingredient: Lamotrigine 100mg
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: Lamictal
Active Ingredient: Lamotrigine 200mg
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: 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 0.25Ág
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 0.5Ág
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 1Ág/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).