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: Attenta
Active Ingredient(s): Methylphenidate hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Product: Colgate Neutrafluor 900 Weekly Fluoride Rinse
Active Ingredient(s): Sodium fluoride 0.2%w/v equivalent to 900ppm fluoride ion
Dosage Form: Mouthwash
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer(s): Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Postinor-2
Active Ingredient(s): Levonorgestrel 750µg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer(s): Gedeon Richter Limited, Budapest, Hungary
Product: Propofol Injection Emulsion
Active Ingredient(s): Propofol 10mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Gensia Laboratories Limited, Irvine, California, United States of America
Product: Relpax
Active Ingredient(s): Eletriptan hydrobromide 24.242mg equivalent to 20mg eletriptan
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Heinrich Mack Nachf, Illertissen, Bavaria, Germany
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Relpax
Active Ingredient(s): Eletriptan hydrobromide 48.485mg equivalent to 40mg eletriptan
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Heinrich Mack Nachf, Illertissen, Bavaria, Germany
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Relpax
Active Ingredient(s): Eletriptan hydrobromide 96.97mg equivalent to 80mg eletriptan
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Heinrich Mack Nachf, Illertissen, Bavaria, Germany
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Tikosyn
Active Ingredient(s): Dofetilide 125µg
Dosage Form: Capsule
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Pfizer Pty Limited, West Ryde, New South Wales, Australia
Pfizer S.A., Amboise Cedex, France
Product: Tikosyn
Active Ingredient(s): Dofetilide 250µg
Dosage Form: Capsule
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Pfizer Pty Limited, West Ryde, New South Wales, Australia
Pfizer S.A., Amboise Cedex, France
Product: Tikosyn
Active Ingredient(s): Dofetilide 500µg
Dosage Form: Capsule
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Pfizer Pty Limited, West Ryde, New South Wales, Australia
Pfizer S.A., Amboise Cedex, France
Product: Zeldox
Active Ingredient(s): Ziprasidone hydrochloride (monohydrate) 113.25mg equivalent to 100mg ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Heinrich Mack Nachf, Illertissen, Bavaria, Germany
Pfizer Pty Limited, West Ryde, New South.Wales, Australia
Product: Zeldox
Active Ingredient(s): Ziprasidone hydrochloride (monohydrate) 22.65mg equivalent to 20mg ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Heinrich Mack Nachf, Illertissen, Bavaria, Germany
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Zeldox
Active Ingredient(s): Ziprasidone hydrochloride (monohydrate) 45.3mg equivalent to 40mg ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Heinrich Mack Nachf, Illertissen, Bavaria, Germany
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Zeldox
Active Ingredient(s): Ziprasidone hydrochloride (monohydrate) 67.95mg equivalent to 60mg ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Heinrich Mack Nachf, Illertissen, Bavaria, Germany
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Zeldox
Active Ingredient(s): Ziprasidone hydrochloride (monohydrate) 90.6mg equivalent to 80mg ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Heinrich Mack Nachf, Illertissen, Bavaria, Germany
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Dated this 15th day of April 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).