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: Escitalopram
Active Ingredient: Escitalopram oxalate 6.388mg equivalent to Escitalopram 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Air Flow Products Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Escitalopram
Active Ingredient: Escitalopram oxalate 12.776mg equivalent to Escitalopram 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Air Flow Products Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Escitalopram
Active Ingredient: Escitalopram oxalate 25.552mg equivalent to Escitalopram 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Air Flow Products Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Montelukast Actavis 4
Active Ingredient: Montelukast sodium 4.16mg equivalent to Montelukast 4mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Montelukast Actavis 5
Active Ingredient: Montelukast sodium 5.2mg equivalent to Montelukast 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Montelukast Actavis 10
Active Ingredient: Montelukast sodium 10.4mg equivalent to Montelukast 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Reutenox
Active Ingredient: Tenoxicam 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: ABM Pharma Limited
Manufacturer: Laboratorios Rubio SA, Barcelona, Spain
Dated this 24th day of April 2014.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).