Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the act and are set out in the schedule hereto:
Schedule
Product: AHF (High Purity) Dried Factor VIII Fraction
Active Ingredient(s): Factor VIII (human) 250IU
Dosage Form: Powder for injection
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Albumex 20
Active Ingredient(s): Albumin 200g/L
Dosage Form: Solution for infusion
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Albumex 4
Active Ingredient(s): Albumin 40g/L
Dosage Form: Solution for infusion
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: H-B-Vax II vaccine
Active Ingredient(s): Hepatitis B vaccine (rDNA) 10µg/mL
Dosage Form: Solution for injection
NZ Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Hepatitis B Immunoglobulin
Active Ingredient(s): Hepatitis B immunoglobulin (human) 160mg/mL
Dosage Form: Solution for injection
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Intragam
Active Ingredient(s): Immunoglobulin G 60mg/mL
Dosage Form: Solution for infusion
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Iomeron
Active Ingredient(s): Iomeprol 306mg
Dosage Form: Solution for injection
NZ Sponsor: Henry Schein Regional Limited
Manufacturer(s): Bracco SpA., Milano, Italy
Product: Iomeron
Active Ingredient(s): Iomeprol 408mg
Dosage Form Solution for injection
NZ Sponsor: Henry Schein Regional Limited
Manufacturer(s): Bracco SpA., Milano, Italy
Product: Iomeron
Active Ingredient(s): Iomeprol 510mg
Dosage Form: Solution for injection
NZ Sponsor: Henry Schein Regional Limited
Manufacturer(s): Bracco SpA., Milano, Italy
Product: Iomeron
Active Ingredient(s): Iomeprol 612mg
Dosage Form: Solution for injection
NZ Sponsor: Henry Schein Regional Limited
Manufacturer(s): Bracco SpA., Milano, Italy
Product: Iomeron
Active Ingredient(s): Iomeprol 714mg
Dosage Form: Solution for injection
NZ Sponsor: Henry Schein Regional Limited
Manufacturer(s): Bracco SpA., Milano, Italy
Product: Iomeron
Active Ingredient(s): Iomeprol 816mg
Dosage Form: Solution for injection
NZ Sponsor: Henry Schein Regional Limited
Manufacturer(s): Bracco SpA., Milano, Italy
Product: MonoFix-VF
Active Ingredient(s): Factor IX 50IU/mL
Dosage Form: Powder for injection
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Normal Immunoglobulin
Active Ingredient(s): Immunoglobulin G 160mg/mL
Dosage Form: Solution for injection
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Prothrombinex-HT
Active Ingredient(s): FactorII500IU
FactorIX500IU
Factor X 500IU
Dosage Form: Powder for injection
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Rh(D) Immunoglobulin
Active Ingredient(s): Anti-D (Rho) immunoglobulin 250IU
Dosage Form: Solution for injection
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Rh(D) Immunoglobulin
Active Ingredient(s): Anti-D (Rho) immunoglobulin 625IU
Dosage Form: Solution for injection
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Tetanus Immunoglobulin
Active Ingredient(s): Tetanus immunoglobulin (human) 250IU
Dosage Form: Solution for injection
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Thrombotrol-VF
Active Ingredient(s): Antithrombin III 1,000IU
Dosage Form: Powder for injection
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Zoster Immunoglobulin
Active Ingredient(s): Zoster immunoglobulin (human) 100IU/mL
Dosage Form: Solution for injection
NZ Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Dated this 16th day of February 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).