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: Anzatax
Active Ingredient(s): Paclitaxel 6mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Begrivac
Active Ingredient(s): Influenza virus haemagglutinin type A/Beijing/262/95-like (H1N1) 15µg/dose
Influenza virus haemagglutinin type A/Sydney/5/97-like (H3N2) 15µg/dose
Influenza virus haemagglutinin type B/Beijing/184/93-like 15µg/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: Multichem Laboratories Limited
Manufacturer(s): Chiron Behring GmbH & Co, Marburg, Germany
Product: Captohexal
Active Ingredient(s): Captopril 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Hexal New Zealand Limited
Manufacturer(s): Hexal-Pharma GmbH, Holzkirchen, Germany
Product: Captohexal
Active Ingredient(s): Captopril 25mg
Dosage Form: Tablet
New Zealand Sponsor: Hexal New Zealand Limited
Manufacturer(s): Hexal-Pharma GmbH, Holzkirchen, Germany
Product: Captohexal
Active Ingredient(s): Captopril 50mg
Dosage Form: Tablet
New Zealand Sponsor: Hexal New Zealand Limited
Manufacturer(s): Hexal-Pharma GmbH, Holzkirchen, Germany
Product: Hycamtin
Active Ingredient(s): Topotecan hydrochloride 1.24mg equivalent to 1.1mg topotecan free base
Dosage Form: Powder for infusion
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Pharmaceuticals, Conshohocken, Pennsylvania, United States of America
Product: Invicorp 1 Autoinjector
Active Ingredient(s): Phentolamine mesylate 1mg
Vasoactive intestinal polypeptide 25µg
Dosage Form: Solution for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer(s): Novocol Pharmaceuticals of Canada Inc., Cambridge, Ontario, Canada
Product: Invicorp 1
Active Ingredient(s): Phentolamine mesylate 1mg
Vasoactive intestinal polypeptide 25µg
Dosage Form: Solution for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer(s): Medeva Pharma Limited, Vale of Bardsley, Ashton-Under-Lyne, Lancashire, England
Product: Invicorp 2 Autoinjector
Active Ingredient(s): Phentolamine mesylate 2mg
Vasoactive intestinal polypeptide 25µg
Dosage Form: Solution for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer(s): Novocol Pharmaceuticals of Canada Inc., Cambridge, Ontario, Canada
Product: Invicorp 2
Active Ingredient(s): Phentolamine mesylate 2mg
Vasoactive intestinal polypeptide 25µg
Dosage Form: Solution for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer(s): Medeva Pharma Limited, Vale of Bardsley, Ashton-Under-Lyne, Lancashire, England
Dated this 14th day of June 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).