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: Seretide Accuhaler
Active Ingredients: Fluticasone propionate 100Ág
Salmeterol xinafoate 72.5Ág equivalent to 50Ág of salmeterol base
Dosage Form: Powder for inhalation
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer: Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom
Product: Seretide Accuhaler
Active Ingredients: Fluticasone propionate 250Ág
Salmeterol xinafoate 72.5Ág equivalent to 50Ág of salmeterol base
Dosage Form: Powder for inhalation
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturers: Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide Accuhaler
Active Ingredients: Fluticasone propionate 500Ág
Salmeterol xinafoate 72.5Ág equivalent to 50Ág of salmeterol base
Dosage Form: Powder for inhalation
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer: Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom
Product: Seretide
Active Ingredients: Fluticasone propionate 20mg equivalent to 125Ág/dos
Salmeterol xinafoate 5.8mg equivalent to 25Ág/dose salmeterol
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturers: Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide
Active Ingredients: Fluticasone propionate 40mg equivalent to 250Ág/dos
Salmeterol xinafoate 5.8mg equivalent to 25Ág/dose salmeterol
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturers: Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide
Active Ingredients: Fluticasone propionate 8mg equivalent to 50Ág/dos
Salmeterol xinafoate 5.8mg equivalent to 25Ág/dose salmeterol
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturers: Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Glaxo Wellcome Production, Evreux, France
Dated this 5th day of June 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).