Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the schedule hereto:
Schedule
Product: Antistine-Privine
Active Ingredient(s): Naphazoline nitrate 0.025%w/v
Antazoline sulphate 0.5%w/v
Dosage Form: Eye irrigation
New Zealand Sponsor: Ciba Vision New Zealand
Manufacturer(s): Ciba Vision AG, Hettlingen, Switzerland
Product: Arniflora
Active Ingredient(s): Arnica montana (flowers) 8%w/w
Dosage Form: Topical gel
New Zealand Sponsor: Vision Holdings Limited
Manufacturer(s): Boericke & Tafel, Santa Rosa, California, United States of America
Product: Boston One Step Liquid Enzymatic Cleaner
Active Ingredient(s): Protease 10mg/g
Dosage Form: Contact lens solution
New Zealand Sponsor: Bausch and Lomb (NZ) Limited
Manufacturer(s): Bausch & Lomb Pharmaceuticals, Tampa, Florida, United States of America
Product: Difflam Anti-inflammatory Anti-bacterial Lozenges (Honey lemon flavour)
Active Ingredient(s): Benzydamine hydrochloride 3mg
Cetylpyridinium chloride 1.33mg
Dosage Form: Lozenge
New Zealand Sponsor: 3M Pharmaceuticals - a division of 3M New Zealand Limited
Manufacturer(s): 3M Pharmaceuticals (Australia) Pty Limited, Thornleigh, New South Wales, Australia Barratts Pharmaceuticals Pty Limited (Div of Nestle), Blacktown, New South Wales, Australia
Product: Difflam Anti-inflammatory Anti-bacterial Lozenges (Orange flavour)
Active Ingredient(s): Benzydamine hydrochloride 3mg
Cetylpyridinium chloride 1.33mg
Dosage Form: Lozenge
New Zealand Sponsor: 3M Pharmaceuticals - a division of 3M New Zealand Limited
Manufacturer(s): 3M Pharmaceuticals (Australia) Pty Limited, Thornleigh, New South Wales, Australia
Barratts Pharmaceuticals Pty Limited (Div of Nestle), Blacktown, New South Wales, Australia
Product: Dosan
Active Ingredient(s): Doxazosin mesylate 2.426mg equivalent to 2mg doxazosin
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Genpharm Inc., Etobicoke, Ontario, Canada
Product: Dosan
Active Ingredient(s): Doxazosin mesylate 4.852mg equivalent to 4mg doxazosin
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Genpharm Inc., Etobicoke, Ontario, Canada
Product: Humalog Mix 25
Active Ingredient(s): Insulin lispro 100U/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Eli Lilly & Co, Lilly Technology Centre, Indianapolis, Indiana, United States of America
Lilly France SA, Fegersheim, France
Product: Humalog Mix25 pen
Active Ingredient(s): Insulin lispro 100U/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Lilly France SA, Fegersheim, France
Product: Humalog Mix50 pen
Active Ingredient(s): Insulin lispro 100U/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Lilly France SA, Fegersheim, France
Product: Humalog Mix50
Active Ingredient(s): Insulin lispro 100U/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Eli Lilly & Co, Lilly Technology Centre, Indianapolis, Indiana, United States of America
Lilly France SA, Fegersheim, France
Product: Humalog NPL Pen
Active Ingredient(s): Insulin lispro 100U/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Lilly France SA, Fegersheim, France
Product: Humalog NPL
Active Ingredient(s): Insulin lispro 100U/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Eli Lilly & Co, Lilly Technology Centre, Indianapolis, Indiana, United States of America
Lilly France SA, Fegersheim, France
Product: Hylaform
Active Ingredient(s): Hylan polymer 5.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Collagen Biomedical Pty Limited
Manufacturer(s): Biomatrix Medical Canada Inc, Pointe-Claire, Quebec, Canada
Product: Ospamox
Active Ingredient(s): Amoxycillin (trihydrate) 287mg equivalent to amoxycillin 250mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Tirol, Austria
Product: Ospamox
Active Ingredient(s): Amoxycillin (trihydrate) 574mg equivalent to amoxycillin 500mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Tirol, Austria
Product: Teveten
Active Ingredient(s): Eprosartan mesylate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Russells Pharmaceuticals Limited
Manufacturer(s): SmithKline Beecham Pharmaceuticals Limited, Magpie Wood, Manor Royal, Crawley, Sussex, England
Product: Teveten
Active Ingredient(s): Eprosartan mesylate 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Russells Pharmaceuticals Limited
Manufacturer(s): SmithKline Beecham Pharmaceuticals Limited, Magpie Wood, Manor Royal, Crawley, Sussex, England
Product: Teveten
Active Ingredient(s): Eprosartan mesylate 400
Dosage Form: Film coated tablet
New Zealand Sponsor: Russells Pharmaceuticals Limited
Manufacturer(s): SmithKline Beecham Pharmaceuticals Limited, Magpie Wood, Manor Royal, Crawley, Sussex, England
Product: Vergo 16
Active Ingredient(s): Betahistine dihydrochloride 16mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Gerard Laboratories, Dublin, Eire
Product: Vicks Sinex 12 Hour Nasal Spray
Active Ingredient(s): Oxymetazoline hydrochloride 0.05%w/v
Dosage Form: Nasal spray solution
New Zealand Sponsor: Procter & Gamble NPD Inc
Manufacturer(s): Olay Company Inc., Barrio Rio Llano, Cayey, Puerto Rico
Product: Vicks Sinex 12 Hour Ultra Fine Mist
Active Ingredient(s): Oxymetazoline hydrochloride 0.05%w/v
Dosage Form: Nasal spray solution
New Zealand Sponsor: Procter & Gamble NPD Inc
Manufacturer(s): Olay Company Inc., Barrio Rio Llano, Cayey, Puerto Rico
Dated this 27th 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).