Medicines Distribution Consent




13 JUNE

NEW ZEALAND GAZETTE

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Product:
Seretide Accuhaler

Active Ingredients:
Fluticasone propionate 250µg
Salmeterol xinafoate 72.5µg equivalent to 50µg 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 500µg
Salmeterol xinafoate 72.5µg equivalent to 50µg 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 125µg/dos
Salmeterol xinafoate 5.8mg equivalent to 25µg/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 250µg/dos
Salmeterol xinafoate 5.8mg equivalent to 25µg/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 50µg/dos
Salmeterol xinafoate 5.8mg equivalent to 25µg/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).

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Consent to the Distribution of Changed Medicines

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use 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:
Zeffix

Active Ingredient:
Lamivudine 5mg/mL

Dosage Form:
Oral solution

New Zealand Sponsor:
Glaxo Wellcome New Zealand Limited

Manufacturer:
Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom

Note: This product has consent that expires on 17 September 2004.

Product:
Zeffix

Active Ingredient:
Lamivudine 100mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Glaxo Wellcome New Zealand Limited

Manufacturer:
Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom

Note: This product has consent that expires on 17 September 2004.

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).

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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2002, No 62


Gazette.govt.nz PDF NZ Gazette 2002, No 62





✨ LLM interpretation of page content

🏥 Consent to the Distribution of Changed Medicines (continued from previous page)

🏥 Health & Social Welfare
5 June 2002
Medicines Act 1981, Changed Medicines, Distribution Consent, Seretide, Zeffix
  • G. R. Boyd, Chief Advisor, Safety and Regulation