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: Ascor L 500
Active Ingredient: Ascorbic acid 500mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Centre for Advanced Medicine
Manufacturer: McGuff Pharmaceuticals Incorporated, Santa Ana, California, United States of America
Product: Azarga
Active Ingredients: Brinzolamide 10mg/mL
Timolol maleate 6.8mg/mL equivalent to 5mg/mL (0.5%) timolol as free base
Dosage Form: Eye drops, suspension
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Rijksweg, Belgium
Product: Carvedilol Tablets 12.5mg
Active Ingredient: Carvedilol 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Norton Healthcare Limited (NZ Branch Office)
Manufacturer: Teva Pharmaceutical Industries Ltd, Kfar Saba, Israel
Product: Carvedilol Tablets 25mg
Active Ingredient: Carvedilol 25mg
Dosage Form: Tablet
New Zealand Sponsor: Norton Healthcare Limited (NZ Branch Office)
Manufacturer: Teva Pharmaceutical Industries Limited, Kfar Saba, Israel
Product: Carvedilol Tablets 3.125mg
Active Ingredient: Carvedilol 3.125mg
Dosage Form: Tablet
New Zealand Sponsor: Norton Healthcare Limited (NZ Branch Office)
Manufacturer: Teva Pharmaceutical Industries Ltd, Kfar Saba, Israel
Product: Carvedilol Tablets 6.25mg
Active Ingredient: Carvedilol 6.25mg
Dosage Form: Tablet
New Zealand Sponsor: Norton Healthcare Limited (NZ Branch Office)
Manufacturer: Teva Pharmaceutical Industries Ltd, Kfar Saba, Israel
Product: OxyContin
Active Ingredient: Oxycodone hydrochloride 60mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Bard Pharmaceuticals Ltd, Cambridge, United Kingdom
Product: OxyContin
Active Ingredient: Oxycodone hydrochloride 120mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Bard Pharmaceuticals Ltd, Cambridge, United Kingdom
Product: Pamol Infant Drops (Strawberry Flavour)
Active Ingredient: Paracetamol 50mg/mL
Dosage Form: Oral drops
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Ensign Laboratories Property Limited, Victoria, Australia
Dated this 15th day of January 2010.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).