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: Apo-Timop
Active Ingredient(s): Timolol maleate 3.4mg/mL equivalent to 2.5mg/mL timolol
Dosage Form: Eye drops, solution
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Novex Pharma Inc, Richmond Hill, Ontario, Canada
Product: Apo-Timop
Active Ingredient(s): Timolol maleate 6.8mg/mL equivalent to 5mg/mL timolol
Dosage Form: Eye drops, solution
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Novex Pharma Inc, Richmond Hill, Ontario, Canada
Product: Etopophos
Active Ingredient(s): Etoposide phosphate 1,159mg equivalent to 1000mg etoposide
Dosage Form: Powder for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Bristol-Caribbean Inc, Foreign Trade Zone 7, Mayaguez, Puerto Rico
Product: Etopophos
Active Ingredient(s): Etoposide phosphate 579.4mg equivalent to 500mg etoposide
Dosage Form: Powder for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Bristol-Caribbean Inc, Foreign Trade Zone 7, Mayaguez, Puerto Rico
Product: Panadol Extra
Active Ingredient(s): Paracetamol 500mg
Caffeine 65mg
Dosage Form: Film coated tablet
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Ireland, Knockbrack, Dungarvan, Co., Waterford, Eire
Product: Pneumo 23
Active Ingredient(s): Pneumococcal Polysaccharide type 1 25µg
Pneumococcal Polysaccharide type 10A 25µg
Pneumococcal Polysaccharide type 11A 25µg
Pneumococcal Polysaccharide type 12F 25µg
Pneumococcal Polysaccharide type 14 25µg
Pneumococcal Polysaccharide type 15B 25µg
Pneumococcal Polysaccharide type 17F 25µg
Pneumococcal Polysaccharide type 18C 25µg
Pneumococcal Polysaccharide type 19A 25µg
Pneumococcal Polysaccharide type 19F 25µg
Pneumococcal Polysaccharide type 2 25µg
Pneumococcal Polysaccharide type 20 25µg
Pneumococcal Polysaccharide type 22F 25µg
Pneumococcal Polysaccharide type 23F 25µg
Pneumococcal Polysaccharide type 3 25µg
Pneumococcal Polysaccharide type 33F 25µg
Pneumococcal Polysaccharide type 4 25µg
Pneumococcal Polysaccharide type 5 25µg
Pneumococcal Polysaccharide type 6B 25µg
Pneumococcal Polysaccharide type 7F 25µg
Pneumococcal Polysaccharide type 8 25µg
Pneumococcal Polysaccharide type 9N 25µg
Pneumococcal Polysaccharide type 9V 25µg
Dosage Form: Suspension for injection
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): Aventis Pasteur SA, Marcy L'Etoile, France
Dated this 23rd day of May 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).