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: Abraxane
Active Ingredient: Paclitaxel 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Specialised Therapeutics Limited
Manufacturers: APP Pharmaceuticals LLC, Illinois, United States of America
APP Pharmaceuticals LLC, New York, United States of America
Abraxis BioScience LLC, Illinois, United States of America
Abraxis BioScience LLC, New York, United States of America
Product: Confirm
Active Ingredients: Goat anti-alpha-hCG polyclonal antibody 0.05µg
Goat anti-mouse polyclonal antibody 0.05µg
Murine monoclonal antibody to beta HCG 0.05µg
Dosage Form: Pregnancy test kit
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Germaine Laboratories Inc., San Antonio, United States of America
Product: Diamide Relief (Pharmacy Only)
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bommasandra, India
Product: Diamide Relief (Prescription)
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bommasandra, India
Product: Ibucode Plus
Active Ingredients: Codeine phosphate, hemihydrate 12.8mg
Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bommasandra, India
Product: Isopto Carpine
Active Ingredient: Pilocarpine hydrochloride 10mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium
Product: Isopto Carpine
Active Ingredient: Pilocarpine hydrochloride 20mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium
Product: Isopto Carpine
Active Ingredient: Pilocarpine hydrochloride 40mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium
Product: Paracetamol 120mg/5 mL
Active Ingredient: Paracetamol 2.4%w/v
Dosage Form: Oral suspension
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Mediorals Laboratories Pvt Limited, Satara, India
Product: Paracetamol 250mg/5 mL
Active Ingredient: Paracetamol 5%w/v
Dosage Form: Oral suspension
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Mediorals Laboratories Pvt Limited, Satara, India
Product: Ropaccord
Active Ingredient: Ropinirole hydrochloride 0.285mg equivalent to 0.25mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Ropaccord
Active Ingredient: Ropinirole hydrochloride 0.57mg equivalent to 0.5mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Ropaccord
Active Ingredient: Ropinirole hydrochloride 1.14mg equivalent to 1mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Ropaccord
Active Ingredient: Ropinirole hydrochloride 2.28mg equivalent to 2mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Visacor
Active Ingredient: Rosuvastatin calcium 5.2mg equivalent to 5mg rosuvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: IPR Pharmaceuticals Inc, Carolina, Puerto Rico
IPR Pharmaceuticals Inc, Canovanas, Puerto Rico
Product: Visacor
Active Ingredients: Rosuvastatin calcium 10.4mg equivalent to 10mg rosuvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: IPR Pharmaceuticals Inc, Carolina, Puerto Rico
IPR Pharmaceuticals Inc, Canovanas, Puerto Rico
Corden Pharma GmbH, Plankstadt, Germany
Product: Visacor
Active Ingredient: Rosuvastatin calcium 20.8mg equivalent to 20mg rosuvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: IPR Pharmaceuticals Inc, Carolina, Puerto Rico
IPR Pharmaceuticals Inc, Canovanas, Puerto Rico
Corden Pharma GmbH, Plankstadt, Germany
Product: Visacor
Active Ingredient: Rosuvastatin calcium 41.6mg equivalent to 40mg rosuvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: IPR Pharmaceuticals Inc, Carolina, Puerto Rico
IPR Pharmaceuticals Inc, Canovanas, Puerto Rico
Corden Pharma GmbH, Plankstadt, Germany
Dated this 8th day of July 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).