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: Methotrexate Onco-Vial
Active Ingredient: Methotrexate 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Methotrexate Onco-Vial
Active Ingredient: Methotrexate 25mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Methotrexate
Active Ingredient: Methotrexate 25mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Methotrexate
Active Ingredient: Methotrexate 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Methotrexate
Active Ingredient: Methotrexate 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Methotrexate
Active Ingredient: Methotrexate 2.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Methotrexate
Active Ingredient: Methotrexate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Farmos Group Limited, Laake Medipolar, Turku, Finland
Product: Methotrexate
Active Ingredient: Methotrexate 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Farmos Group Limited, Laake Medipolar, Turku, Finland
Product: Somac
Active Ingredient: Pantoprazole sodium 22.57mg equivalent to 20mg Pantoprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer(s): Byk Gulden Lomberg Chemische Fabrik GmbH, Konstanz, Germany
Oranienburger Pharmawerk GmbH, Oranienburg, Germany
Product: Taxol
Active Ingredient: Paclitaxel 6mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Caribbean Inc, Mayaguez, Puerto Rico
Dated this 16th day of January 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).