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: AFT-Pamidronate 30mg
Active Ingredient: Pamidronic acid 26mg equivalent to 30.9mg pamidronic acid disodium
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Draxis Pharma Inc., Kirkland, Canada
Product: AFT-Pamidronate 60mg
Active Ingredient: Pamidronic acid 51.96mg equivalent to 61.74mg pamidronic acid disodium
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Draxis Pharma Inc., Kirkland, Canada
Product: AFT-Pamidronate 90mg
Active Ingredient: Pamidronic acid 78.05mg equivalent to 92.75mg pamidronic acid disodium
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Draxis Pharma Inc., Kirkland, Canada
Product: Atenolol
Active Ingredient: Atenolol 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: IPCA Pharma (NZ) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli, India
Product: Atenolol
Active Ingredient: Atenolol 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: IPCA Pharma (NZ) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli, India
Product: Atenolol
Active Ingredient: Atenolol 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: IPCA Pharma (NZ) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli, India
Product: Crestor
Active Ingredient: Rosuvastatin calcium 5.2mg equivalent to rosuvastatin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: IPR Pharmaceuticals Inc, San Isidro Industrial Park, Canovanas, Puerto Rico
IPR Pharmaceuticals Inc, South Main Street, Carolina, Puerto Rico
Product: Definity
Active Ingredient: Perflutren 1.1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product: Nurofen Back Pain
Active Ingredient: Ibuprofen lysinate 342mg equivalent to 200mg ibuprofen
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham Site, Nottinghamshire, United Kingdom
Product: ProQuad
Active Ingredients: Measles vaccine, live attenuated 1,000TCID50
Mumps virus, Jeryl-Lynn strain 19,952TCID50
Rubella virus, Wistar RA27/3 strain 1,000TCID50
Varicella vaccine 9,772PFU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Tenolol
Active Ingredient: Atenolol 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: IPCA Pharma (NZ) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli, India
Product: Tenolol
Active Ingredient: Atenolol 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: IPCA Pharma (NZ) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli, India
Product: Tenolol
Active Ingredient: Atenolol 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: IPCA Pharma (NZ) Pty Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli, India
Dated this 30th day of November 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).