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: Advil Mini Caps (General Sale)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Wyeth Consumer Healthcare A Division of Wyeth (NZ) Limited
Manufacturer: Wyeth SpA, Aprilia (Lt), Italy
Product: Apo-Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 291.5mg equivalent to ciprofloxacin 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Apo-Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 583mg equivalent to ciprofloxacin 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Apo-Ciprofloxacin
Active Ingredient: Ciprofloxacin hydrochloride 873mg equivalent to ciprofloxacin 750mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Azromycin
Active Ingredient: Azithromycin monohydrate 263.68mg equivalent to azithromycin 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: McDermott Laboratories, t/a Gerard Laboratories, Dublin, Ireland
Product: Azromycin
Active Ingredient: Azithromycin monohydrate 527.36mg equivalent to azithromycin 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: McDermott Laboratories, t/a Gerard Laboratories, Dublin, Ireland
Product: Ceftriaxone
Active Ingredient: Ceftriaxone sodium 1.183g equivalent to ceftriaxone 1g
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Reig Jofre SA, Sant Adria de Besos, Barcelona, Spain
Product: Ceftriaxone
Active Ingredient: Ceftriaxone sodium 1.183g equivalent to ceftriaxone 1g
Dosage Form: Powder for injection
Manufacturer: Reig Jofre SA, Sant Adria de Besos, Barcelona, Spain
Dosage Form: Diluent
Manufacturer: Reig Jofre SA, Sant Joan Despi, Barcelona, Spain
New Zealand Sponsor: Multichem NZ Limited
Product: Codral Nightime
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer: Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
Product: Formoterol Clickhaler Merck 12
Active Ingredient: Formoterol fumarate 0.42%w/w
Dosage Form: Powder for inhalation
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Celltech Manufacturing Services Limited, Vale of Bardsley, Lancashire, United Kingdom
Product: Oratane
Active Ingredient: Isotretinoin 40mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Swiss Caps AG, Kirchberg, Switzerland
Dated this 7th day of July 2006.
SALLY GILBERT, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).