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: Aranesp
Active Ingredient(s): darbepoetin alfa 100µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Lmited
Manufacturer(s): Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient(s): darbepoetin alfa 15µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer(s): Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient(s): darbepoetin alfa 200µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer(s): Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient(s): darbepoetin alfa 25µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer(s): Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient(s): darbepoetin alfa 40µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer(s): Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient(s): darbepoetin alfa 500µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer(s): Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Aranesp
Active Ingredient(s): darbepoetin alfa 60µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Branch Amgen Australia Pty Limited
Manufacturer(s): Amgen Puerto Rico Inc., Juncos, Puerto Rico
Product: Cefotaxime Injection
Active Ingredient(s): Cefotaxime sodium 1048.2mg equivalent to 1000mg cefotaxime
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Cefotaxime Injection
Active Ingredient(s): Cefotaxime sodium 2096.4mg equivalent to 2000mg cefotaxime
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Cefotaxime Injection
Active Ingredient(s): Cefotaxime sodium 524.1mg equivalent to 500mg cefotaxime
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Clorotir
Active Ingredient(s): Cefaclor (monohydrate) 26.224mg/mL equivalent to 25mg cefaclor
Dosage Form: Granules for oral suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Clorotir
Active Ingredient(s): Cefaclor (monohydrate) 52.45mg/mL equivalent to 50mg cefaclor
Dosage Form: Granules for oral suspension
New Zealand Sponsor: Novartis New Zealand Ltd
Manufacturer(s): Biochemie GmbH, Biochemiestrasse 10, Kundl, Austria
Product: DermAid Soft 0.5% Cream
Active Ingredient(s): Hydrocortisone 0.5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia
Product: DermAid Soft 1% Cream
Active Ingredient(s): Hydrocortisone 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia
Product: Lamisil Dermgel
Active Ingredient(s): Terbinafine 1%w/w
Dosage Form: Topical gel
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma GmbH, Wehr, Germany
Product: Mylanta P
Active Ingredient(s): Aluminium/magnesium Co-Gel C655 0mg/mL
Simethicone 4mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Warner Lambert Consumer Group Div. of Pfizer Laboratories Limited
Manufacturer(s): Parke Davis Pty Limited, Caringbah, Sydney, New South Wales, Australia
Dated this 18th day of July 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).