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: Avaxim
Active Ingredient(s): Hepatitis A virus formaldehyde inactivated (GBM strain) 160U
Dosage Form: Suspension for injection
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): Aventis Pasteur SA, Marcy L'Etoile, France
Product: Biostate
Active Ingredient(s): Dried factor VIII fraction 250IU
Dosage Form: Powder for injection
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Cefazolin Injection
Active Ingredient(s): Cephazolin sodium 524mg equivalent to 0.5g cefazolin
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Cefazolin Injection
Active Ingredient(s): Cephazolin sodium 1,048mg equivalent to 1g cefazolin
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Cefotaxime Sodium for Injection
Active Ingredient(s): Cefotaxime sodium 1.048g equivalent to 1g cefotaxime
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Anfarm Hellas SA, Athens, Greece
Product: Cefotaxime Sodium for Injection
Active Ingredient(s): Cefotaxime sodium 2.096g equivalent to 2g cefotaxime
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Anfarm Hellas SA, Athens, Greece
Product: Cefotaxime Sodium for Injection
Active Ingredient(s): Cefotaxime sodium 525mg equivalent to 500mg cefotaxime
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Anfarm Hellas SA, Athens, Greece
Product: Fluphenazine Decanoate Injection BP
Active Ingredient(s): Fluphenazine decanoate 100mg/mL
Dosage Form: Injection (depot)
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): David Bull Laboratories Ltd, Mulgrave North, Victoria, Australia
Product: Prograf
Active Ingredient(s): Tacrolimus 0.5mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Fujisawa Ireland Limited, Killorglin, Co Kerry, Ireland
Product: Tofranil
Active Ingredient(s): Imipramine hydrochloride 10mg
Dosage Form: Coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma AG, Stein, Switzerland
Dated this 21st day of February 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).