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: Diprivan
Active Ingredient(s): Propofol 10mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca SpA, Caponago, Milan, Italy
Fresenius Kabi AB, Stockholm, Sweden
Fresenius Kabi AB, Uppsala, Sweden
Product: Diprivan
Active Ingredient(s): Propofol 20mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca SpA, Caponago, Milan, Italy
Product: Genotropin Miniquick
Active Ingredient(s): Somatropin 0.2mg equivalent to 0.6 IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin Miniquick
Active Ingredient(s): Somatropin 0.4mg equivalent to 1.2 IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin Miniquick
Active Ingredient(s): Somatropin 0.6mg equivalent to 1.8 IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin Miniquick
Active Ingredient(s): Somatropin 0.8mg equivalent to 2.4 IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin Miniquick
Active Ingredient(s): Somatropin 1mg equivalent to 3.0 IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin Miniquick
Active Ingredient(s): Somatropin 1.2mg equivalent to 3.6 IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin Miniquick
Active Ingredient(s): Somatropin 1.4mg equivalent to 4.2 IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin Miniquick
Active Ingredient(s): Somatropin 1.6mg equivalent to 4.8 IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin Miniquick
Active Ingredient(s): Somatropin 1.8mg equivalent to 5.4 IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin Miniquick
Active Ingredient(s): Somatropin 2mg equivalent to 6.0 IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin
Active Ingredient(s): Somatropin 16IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Recip AB., Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Genotropin
Active Ingredient(s): Somatropin 36IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer(s): Recip AB., Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Intragam P
Active Ingredient(s): Immunoglobulin G 0.06g/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Leukeran
Active Ingredient(s): Chlorambucil 2mg
Dosage Form: Tablet
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome Operations, Temple Hill, Dartford, Kent, United Kingdom
Product: Malarone
Active Ingredient(s): Atovaquone 250mg
Proguanil hydrochloride 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome (Canada) Inc., Mississauga, Ontario, Canada
Glaxo Wellcome Operations, Temple Hill, Dartford, Kent, United Kingdom
Dated this 14th day of March 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).