Medicines Consent Notices




170

NEW ZEALAND GAZETTE

No. 8

Health

Medicines Act 1981

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Accuretic

Active Ingredient(s): Hydrochlorothiazide 12.5mg
Quinapril hydrochloride 10.832mg equivalent to 10mg quinapril free base

Dosage Form: Film coated tablet

New Zealand Sponsor: Pfizer Laboratories Limited

Manufacturer(s): Godecke AG, Freiburg, Germany

Product: Accuretic

Active Ingredient(s): Hydrochlorothiazide 12.5mg
Quinapril hydrochloride 21.664mg equivalent to 20mg quinapril free base

Dosage Form: Film coated tablet

New Zealand Sponsor: Pfizer Laboratories Limited

Manufacturer(s): Godecke AG, Freiburg, Germany

Product: Seretide

Active Ingredient(s): Fluticasone propionate 20mg equivalent to 125µg/dose
Salmeterol xinafoate 5.8mg equivalent to 25µg/dose salmeterol

Dosage Form: Aerosol inhaler, metered dose

New Zealand Sponsor: Glaxo Wellcome New Zealand Limited

Manufacturer(s): Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Glaxo Wellcome Production, Evreux, France

Product: Seretide

Active Ingredient(s): Fluticasone propionate 40mg equivalent to 250µg/dose
Salmeterol xinafoate 5.8mg equivalent to 25µg/dose salmeterol

Dosage Form: Aerosol inhaler, metered dose

New Zealand Sponsor: Glaxo Wellcome New Zealand Limited

Manufacturer(s): Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Glaxo Wellcome Production, Evreux, France

Product: Seretide

Active Ingredient(s): Fluticasone propionate 8mg equivalent to 50µg/dose
Salmeterol xinafoate 5.8mg equivalent to 25µg/dose salmeterol

Dosage Form: Aerosol inhaler, metered dose

New Zealand Sponsor: Glaxo Wellcome New Zealand Limited

Manufacturer(s): Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Glaxo Wellcome Production, Evreux, France

Dated this 17th day of January 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).

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Renewal of Provisional Consent to the Distribution of a New Medicine

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 new medicine set out in the Schedule hereto:

Schedule

Product: Temodal

Active Ingredient(s): Temozolomide 100mg

Dosage Form: Capsule

New Zealand Sponsor: Schering-Plough Pty Limited

Manufacturer(s): Integrated Therapeutics Group Inc., Subsidiary Schering-Plough Corp., Iowa City, Iowa, United States of America



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 8


Gazette.govt.nz PDF NZ Gazette 2001, No 8





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
17 January 2001
Medicines Act 1981, New Medicines, Distribution Consent, Pharmaceuticals
  • G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Renewal of Provisional Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
Medicines Act 1981, Provisional Consent, Temodal, Pharmaceuticals