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: Duolin
Active Ingredient(s): Ipratropium bromide (monohydrate) 525µg/dose equivalent to 500µg ipratropium bromide anhydrous./dose
Salbutamol sulphate 3mg/dose equivalent to 2.5mg salbutamol/dose
Dosage Form: Solution for inhalation
New Zealand Sponsor: REX Medical Limited
Manufacturer(s): Cipla Ltd, Vikhroli, Mumbai, Maharashtra, India
Product: FreshLook All-In-One Solution
Active Ingredient(s): Polyhexanide 0.0001%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Ciba Vision New Zealand
Manufacturer(s): Ciba Vision Canada Inc - Sterile Manufacturing, Mississauga, Ontario, Canada
Product: Nicotrol
Active Ingredient(s): Nicotine 0.3125mg/h
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer(s): Pharmacia AB, Consumer Healthcare, Helsingborg, Sweden
Product: Nicotrol
Active Ingredient(s): Nicotine 0.625mg/h
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer(s): Pharmacia AB, Consumer Healthcare, Helsingborg, Sweden
Product: Nicotrol
Active Ingredient(s): Nicotine 0.9375mg/h
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer(s): Pharmacia AB, Consumer Healthcare, Helsingborg, Sweden
Product: Optrex Fresh Eyes
Active Ingredient(s): Witch hazel (distilled) 13%v/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer(s): The Boots Company Plc., Beeston, Nottingham, United Kingdom
Product: Optrex Fresh Eyes
Active Ingredient(s): Witch hazel (distilled) 13%v/v
Dosage Form: Eye irrigation
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer(s): The Boots Company Plc., Beeston, Nottingham, United Kingdom
Product: Walco Quick-Eze
Active Ingredient(s): Calcium carbonate 750mg
Magnesium carbonate 123mg
Magnesium trisilicate (hydrate) 123mg
Dosage Form: Tablet
New Zealand Sponsor: Nestle New Zealand Limited
Manufacturer(s): Nestle Australia Limited, Blacktown, New South Wales, Australia
Dated this 12th day of September 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).