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).