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: Mircera
Active Ingredient: Methoxy polyethylene glycol epoetin beta 30µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Mircera
Active Ingredients: Methoxy polyethylene glycol epoetin beta 50µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Mircera
Active Ingredient: Methoxy polyethylene glycol epoetin beta 75µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Mircera
Active Ingredient: Methoxy polyethylene glycol epoetin beta 100µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Mircera
Active Ingredient: Methoxy polyethylene glycol epoetin beta 120µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Mircera
Active Ingredient: Methoxy polyethylene glycol epoetin beta 150µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Mircera
Active Ingredient: Methoxy polyethylene glycol epoetin beta 200µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Mircera
Active Ingredient: Methoxy polyethylene glycol epoetin beta 250µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Mircera
Active Ingredient: Methoxy polyethylene glycol epoetin beta 360µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Mircera
Active Ingredient: Methoxy polyethylene glycol epoetin beta 600µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Mircera
Active Ingredient: Methoxy polyethylene glycol epoetin beta 800µg
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Omeprazole IV - Rex
Active Ingredient: Omeprazole sodium 42.6mg equivalent to 40mg omeprazole
Dosage Form: Powder for infusion
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Oxaliplatin
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Vianex SA, Pallini Attikis, Greece
Product: Oxaliplatin
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Vianex SA, Pallini Attikis, Greece
Product: Timolol
Active Ingredient: Timolol maleate 0.3417%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Timolol
Active Ingredient: Timolol maleate 0.6834%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Dated this 3rd day of September 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).