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 Childrens Pain & Fever Relief
Active Ingredient: Ibuprofen 20mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Interphil Laboratories Inc, Cabuyao, Philippines
Product: Apo-Olanzapine
Active Ingredient: Olanzapine 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Olanzapine
Active Ingredient: Olanzapine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Olanzapine
Active Ingredient: Olanzapine 7.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Olanzapine
Active Ingredient: Olanzapine 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Olanzapine
Active Ingredient: Olanzapine 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Olanzapine
Active Ingredient: Olanzapine 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Olanzapine ODT
Active Ingredient: Olanzapine 5mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Olanzapine ODT
Active Ingredient: Olanzapine 10mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Olanzapine ODT
Active Ingredient: Olanzapine 15mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Olanzapine ODT
Active Ingredient: Olanzapine 20mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Ceptolate
Active Ingredient: Mycophenolate mofetil 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan LLC, Caguas, Puerto Rico
Product: Roxanne 20/100
Active Ingredients: Ethinylestradiol 20µg
Levonorgestrel 100µg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharbil Waltrop GmbH, Waltrop, Germany
Product: Roxanne 30/150
Active Ingredients: Ethinylestradiol 30µg
Levonorgestrel 150µg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharbil Waltrop GmbH, Waltrop, Germany
Product: Roxanne ED 20/100
Active Ingredients: Ethinylestradiol 20µg
Levonorgestrel 100µg
Dosage Form: Film coated tablet
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharbil Waltrop GmbH, Waltrop, Germany
Product: Roxanne ED 30/150
Active Ingredients: Ethinylestradiol 30µg
Levonorgestrel 150µg
Dosage Form: Film coated tablet
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharbil Waltrop GmbH, Waltrop, Germany
Dated this 6th day of October 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).