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Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Activize
Active Ingredients: Baquacil 0.0001%w/v
Poloxamer 0.05%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Advanced Medical Optics Australia Pty Limited t/a Advanced Medical Optics NZ
Manufacturer: AMO (Hangzhou) Co Limited, Hangzhou, Zhejiang, China
Product: Activize Comfort Drops
Active Ingredients: Hypromellose 0.15%w/v
Trometamol 1.2%w/v
Tyloxapol 0.025%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Advanced Medical Optics Australia Pty Limited t/a Advanced Medical Optics NZ
Manufacturer: AMO (Hangzhou) Co Limited, Hangzhou, Zhejiang, China
Product: Activize RGP Solution
Active Ingredients: Hypromellose 0.15%w/v
Trometamol 1.2%w/v
Tyloxapol 0.025%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Advanced Medical Optics Australia Pty Limited t/a Advanced Medical Optics NZ
Manufacturer: AMO (Hangzhou) Co Limited, Hangzhou, Zhejiang, China
Product: Amyl Nitrite Inhalant
Active Ingredient: Amyl nitrite 98%w/v
Dosage Form: Volatile liquid for inhalation
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: James Alexander Corporation, Blairstown, New Jersey, United States of America
Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Anekal Taluk, Bommasandra, Bangalore, India
Product: Mestinon
Active Ingredient: Pyridostigmine bromide 60mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Valeant Canada Limited, Montreal, Quebec, Canada
Product: Myaccord
Active Ingredient: Mycophenolate mofetil 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India
Product: Optive
Active Ingredients: Carmellose sodium 5mg/mL
Glycerol 9mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturers: Allergan Sales LLC, Waco, Texas, United States of America
Sterigenics US LLC, Santa Teresa, New Mexico, United States of America
Sterigenics US LLC, Fort Worth, Texas, United States of America
Product: Rescriptor
Active Ingredient: Delavirdine mesilate 100mg equivalent to 82.6mg delavirdine
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Pharmaceuticals LLC, Arecibo, Puerto Rico
Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Product: Zarator
Active Ingredient: Atorvastatin calcium 21.69mg equivalent to 20mg Atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, Loughbeg, Ringaskiddy, County Cork, Ireland
Farmea, ZAC Sud d’Orgemont, Angers, France
Product: Zarator
Active Ingredient: Atorvastatin calcium 43.38mg equivalent to 40mg Atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, Loughbeg, Ringaskiddy, County Cork, Ireland
Farmea, ZAC Sud d’Orgemont, Angers, France
Product: Zarator
Active Ingredient: Atorvastatin calcium 86.76mg equivalent to 80mg Atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Pfizer Ireland Pharmaceuticals, Loughbeg, Ringaskiddy, County Cork, Ireland
Product: Zarator
Active Ingredient: Atorvastatin calcium 10.85mg equivalent to 10mg Atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, Loughbeg, Ringaskiddy, County Cork, Ireland
Farmea, ZAC Sud d’Orgemont, Angers, France
Product: Zevalin
Active Ingredient: Ibritumomab tiuxetan 1.6mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Dated this 19th day of October 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).