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: Atridox
Active Ingredient(s): Doxycycline hyclate 50mg equivalent to to 42.5mg doxycycline
Dosage Form: Syringe B Powder for injection
New Zealand Sponsor: The Essential Dental Company Limited
Manufacturer(s): Atrix Laboratories Inc, Fort Collins, Colorado, United States of America
Product: Cosudex
Active Ingredient(s): Bicalutamide 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca GmbH, Plankstadt, Germany
Product: Curam
Active Ingredient(s): Potassium clavulanate 8.6mg/mL equiv to 6.25mg clavulanic acid per ml
Amoxycillin (trihydrate) 28.7mg/mL equivalent to 25mg amoxycillin per ml
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Curam
Active Ingredient(s): Potassium clavulanate 17.2mg/mL equiv to 12.5mg clavulanic acid per ml
Amoxycillin (trihydrate) 57.4mg/mL equiv to 50mg amoxycillin per ml
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Curam
Active Ingredient(s): Amoxycillin (trihydrate) 287mg equivalent to 250mg Amoxycillin
Potassium clavulanate 153mg equivalent to 125mg clavulanic acid
Dosage Form: Film coated tablet
New Zealand Sponsor: Biochemie, a division of Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Curam
Active Ingredient(s): Amoxycillin (trihydrate) 574mg equivalent to 500mg of Amoxycillin
Potassium clavulanate 156mg equivalent to 125mg clavulanic acid
Dosage Form: Film coated tablet
New Zealand Sponsor: Biochemie, a division of Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Glizon
Active Ingredient(s): Gliclazide 80mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Edmond Pharma Srl, Paderno Dugnano, Milano, Italy
Product: Nexium
Active Ingredient(s): Esomeprazole magnesium trihydrate 22.3mg equivalent to 20mg esomeprazole
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
Product: Nexium
Active Ingredient(s): Esomeprazole magnesium trihydrate 44.5mg equivalent to 40mg esomeprazole
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
Product: Norfloxacin
Active Ingredient(s): Norfloxacin 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Cheminor Drugs Limited, Pharma Division, Bollaram, Bachepally, India
Product: Paracetamol (The Order of St John)
Active Ingredient(s): Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, Auckland
Product: Paracetamol (The Order of St John)
Active Ingredient(s): Paracetamol 500mg
Dosage Form: Capsule
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, Auckland
Product: Paracetamol
Active Ingredient(s): Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem Laboratories Limited
Manufacturer(s): IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Predonium DS
Active Ingredient(s): Indapamide (hemihydrate) 1.25mg
Perindopril erbumine 4mg
Dosage Form: Tablet
New Zealand Sponsor: Servier Laboratories Limited
Manufacturer(s): Les Laboratoires Servier Industrie, Gidy, France
Servier (Ireland) Technology, Arklow, County Wicklow, Ireland
Product: Predonium
Active Ingredient(s): Indapamide (hemihydrate) 0.625mg
Perindopril erbumine 2mg
Dosage Form: Tablet
New Zealand Sponsor: Servier Laboratories Limited
Manufacturer(s): Les Laboratoires Servier Industrie, Gidy, France
Servier (Ireland) Technology, Arklow, County Wicklow, Ireland
Product: Velosulin HM(ge)
Active Ingredient(s): Insulin, human (recombinant DNA origin) 100IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer(s): Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Dated this 5th day of January 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).