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: Ascorbic Acid Injection
Active Ingredient(s): Ascorbic acid 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Cefotaxime
Active Ingredient(s): Cefotaxime sodium 1,048.1mg equivalent 1g cefotaxime
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Eczacibasi Ilac Sanayi ve Ticaret AS, Lulebergaz, Kirklareli, Turkey
Product: Cefotaxime
Active Ingredient(s): Cefotaxime sodium 2,096.2mg equivalent 2g cefotaxime
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Eczacibasi Ilac Sanayi ve Ticaret AS, Lulebergaz, Kirklareli, Turkey
Product: Cefotaxime
Active Ingredient(s): Cefotaxime sodium 524.05mg equivalent to 500mg cefotaxime
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Eczacibasi Ilac Sanayi ve Ticaret AS, Lulebergaz, Kirklareli, Turkey
Product: Mintec
Active Ingredient(s): Peppermint oil 180mg equivalent to 0.2mL
Dosage Form: Modified release capsule
New Zealand Sponsor: Wilson Consumer Products
Manufacturer(s): Pan Laboratories (Australia) Pty Limited, Moorebank, New South Wales, Australia
Product: NeutraGard 0.05%
Active Ingredient(s): Sodium fluoride 0.05%w/v
Dosage Form: Topical solution
New Zealand Sponsor: Ivoclar Dental (NZ) Limited
Manufacturer(s): Pascal Company Inc, Bellevue, Washington, United States of America
Product: Soaclens Sterile Soaking and Wetting Solution
Active Ingredient(s): Disodium edetate 0.1%w/v
Polyquaternium - 1 0.0011%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Alcon Cusi, S.A., Alcobendas (Madrid), Spain
Alcon Laboratories Inc, Fort Worth, Texas, United States of America
Dated this 13th day of July 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).