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: Hepatitis B Immunoglobulin 100IU
Active Ingredient(s): Hepatitis B immunoglobulin (human) 160mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Hepatitis B Immunoglobulin 400IU
Active Ingredient(s): Hepatitis B immunoglobulin (human) 160mg/mL
Dosage Form: Solution for injection
New Zealand 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
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Orthoclone OKT3
Active Ingredient(s): Muromonab-CD3 1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Ortho Biotech Products, L.P., Raritan, New Jersey, United States of America
Product: Rh(D) Immunoglobulin
Active Ingredient(s): Anti-D (Rho) immunoglobulin 250IU
Dosage Form: Solution for injection
New Zealand 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
New Zealand 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
New Zealand 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
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Dated this 5th day of June 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).