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: Apo-Famotidine
Active Ingredient(s): Famotidine 20mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: HAES-steril 10%
Active Ingredient(s): Pentastarch 100g/L
Sodium chloride 9g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: REM Systems Limited
Manufacturer(s): Fresenius AG, Friedberg, Germany
Product: HAES-steril 6%
Active Ingredient(s): Pentastarch 60g/L
Sodium chloride 9g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: REM Systems Limited
Manufacturer(s): Fresenius AG, Friedberg, Germany
Product: Multivitamin Tablets
Active Ingredient(s): Ascorbic acid 15mg
Cholecalciferol 7.5Ág
Nicotinamide 7.9mg
Retinol 750Ág
Riboflavin 0.55mg
Thiamine nitrate 1.05mg
Dosage Form: Coated tablet
New Zealand Sponsor: Healtheries of New Zealand Limited
Manufacturer(s): Healtheries of New Zealand Limited, Mt Wellington, Auckland
Product: Spiriva
Active Ingredient(s): Tiotropium bromide monohydrate 22.5Ág equivalent 18 Ág tiotropium
Dosage Form: Powder filled inhalation capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer(s): Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany
Dated this 10th day of October 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).