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: Amlodipine
Active Ingredient: Amlodipine besilate 13.869mg equivalent to10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachepalli, Andhra Pradesh, India
Product: Amlodipine
Active Ingredient: Amlodipine besilate 6.935mg equivalent to 5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachepalli, Andhra Pradesh, India
Product: Aptivus
Active Ingredient: Tipranavir 250mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Catalent Pharma Solutions LLC, St Petersburg, Florida, United States of America
Product: Simlo
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Simlo
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Simlo
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Simlo
Active Ingredient: Simvastatin 80mg
Dosage Form: Film Coated Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Simvastatin
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Simvastatin
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Simvastatin
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Simvastatin
Active Ingredient: Simvastatin 80mg
Dosage Form: Film Coated Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: SmartMix Bowl Pre-filled with SmartSet GMV Endurance Gentamicin
Active Ingredients: Gentamicin sulfate 4.22%w/w
Dosage Forms: Bone cement – powder component
Bone cement – liquid component
New Zealand Sponsor: Johnson & Johnson Medical New Zealand Limited
Manufacturer: DePuy International Limited T/A DePuy CMW, Blackpool, United Kingdom
Product: SmartMix Cemvac pre-filled with DePuy CMW 1 Gentamicin
Active Ingredient: Gentamicin sulfate 4.22%w/w
Dosage Forms: Bone cement – powder component
Bone cement – liquid component
New Zealand Sponsor: Johnson & Johnson Medical New Zealand Limited
Manufacturer: DePuy International Limited T/A DePuy CMW, Blackpool, United Kingdom
Product: SmartMix Cemvac Pre-filled with SmartSet GHV Gentamicin
Active Ingredient: Gentamicin sulfate 4.22%w/w
Dosage Forms: Bone cement – powder component
Bone cement – liquid component
New Zealand Sponsor: Johnson & Johnson Medical New Zealand Limited
Manufacturer: DePuy International Limited T/A DePuy CMW, Blackpool, United Kingdom
Product: SmartMix Cemvac pre-filled with SmartSet GMV Endurance Gentamicin
Active Ingredient: Gentamicin sulfate 4.22%w/w
Dosage Forms: Bone cement – powder component
Bone cement – liquid component
New Zealand Sponsor: Johnson & Johnson Medical New Zealand Limited
Manufacturer: DePuy International Limited T/A DePuy CMW, Blackpool, United Kingdom
Product: SmartSet GMV Endurance Gentamicin Bone Cement
Active Ingredient: Gentamicin sulfate 4.22%w/w
Dosage Forms: Bone cement – powder component
Bone cement – liquid component
New Zealand Sponsor: Johnson & Johnson Medical New Zealand Limited
Manufacturer: DePuy International Limited T/A DePuy CMW, Blackpool, United Kingdom
Product: Strepsils Cool
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Tasmar
Active Ingredient: Tolcapone 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Dated this 7th day of November 2008.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).