Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Loxalate
Active Ingredient: Escitalopram oxalate 25.56mg equivalent to escitalopram 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
Product: Loxalate
Active Ingredient: Escitalopram oxalate 12.78mg equivalent to escitalopram 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
Product: Loxalate
Active Ingredient: Escitalopram oxalate 6.39mg equivalent to escitalopram 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
Product: Apo-Atorvastatin
Active Ingredient: Atorvastatin calcium 11mg equivalent to atorvastatin 10mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Atorvastatin
Active Ingredient: Atorvastatin calcium 22mg equivalent to atorvastatin 20mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Atorvastatin
Active Ingredient: Atorvastatin calcium 44mg equivalent to atorvastatin 40mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Atorvastatin
Active Ingredient: Atorvastatin calcium 88mg equivalent to atorvastatin 80mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Quetiapine
Active Ingredient: Quetiapine fumarate 28.783mg equivalent to quetiapine 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Quetiapine
Active Ingredient: Quetiapine fumarate 115.132mg equivalent to quetiapine 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Quetiapine
Active Ingredient: Quetiapine fumarate 172.698mg equivalent to quetiapine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Quetiapine
Active Ingredient: Quetiapine fumarate 230.264mg equivalent to quetiapine 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Quetiapine
Active Ingredient: Quetiapine fumarate 345.396mg equivalent to quetiapine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Easyvision Multipurpose Solution
Active Ingredient: Polihexanide 0.0001%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Pharmaceutical Marketing New Zealand Ltd
Manufacturer: Sauflon Pharmaceuticals Limited, Kent, United Kingdom
Dated this 29th day of April 2010.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).