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: Augmentin ES
Active Ingredients: Amoxicillin trihydrate 151.808mg/mL equivalent to amoxycillin 120mg/mL
Potassium clavulanate 24.59mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Corporation, Bristol, Tennessee, United States of America
Product: Colgate FluoroCare 5000 Gel-Cool Mint
Active Ingredient: Sodium fluoride 1.07%w/w equivalent to fluoride ion 5000ppm
Dosage Form: Oral topical gel
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer: Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Colgate FluoroCare 5000 Gel-Cherry
Active Ingredient: Sodium fluoride 1.07%w/w equivalent to fluoride ion 5000ppm
Dosage Form: Oral topical gel
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer: Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Micardis Plus
Active Ingredients: Hydrochlorothiazide 12.5mg
Telmisartan 40mg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Micardis Plus
Active Ingredients: Hydrochlorothiazide 12.5mg
Telmisartan 80mg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Panadol Cold & Flu Max Hot Lemon
Active Ingredient: Paracetamol 1000mg
Dosage Form: Powder
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham SA, Alcala de Henares (Madrid), Spain
Product: Reandron 1000
Active Ingredient: Testosterone undecylate 1000mg
Dosage Form: Solution for injection
New Zealand Sponsor: Schering (NZ) Limited
Manufacturers: Jenahexal Pharma GmbH, Jena, Germany
Schering AG, Berlin, Germany
Product: Smartset GHV Gentamicin Bone Cement
Active Ingredient: Gentamicin sulphate 2.9%w/w equivalent to Gentamicin base 1.7% w/w
Dosage Forms: Bone cement – powder component
Bone cement – liquid component
New Zealand Sponsor: DePuy New Zealand Limited
Manufacturer: DePuy CMW, Blackpool, United Kingdom
Dated this 16th day of November 2006.
BARRY BORMAN, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).