Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the schedule hereto:
Schedule
Product: Avapro HCT
Active Ingredient(s): Irbesartan 150mg
Hydrochlorothiazide 12.5mg
Dosage Form: Tablet
NZ Sponsor: Sanofi-Synthelabo (NZ) Limited
Manufacturer(s): Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Product: Avapro HCT
Active Ingredient(s): Irbesartan 300mg
Hydrochlorothiazide 12.5mg
Dosage Form: Tablet
NZ Sponsor: Sanofi-Synthelabo (NZ) Limited
Manufacturer(s): Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Product: Imigran Nasal Spray
Active Ingredient(s): Sumatriptan hemisuccinate 140mg/mL equivalent to 100mg/mL sumatriptan
Dosage Form: Nasal spray solution
NZ Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome SpA, San Polo di Torrile, Parma, Italy
Product: Imigran Nasal Spray
Active Ingredient(s): Sumatriptan hemisuccinate 280mg/mL equivalent to 200mg/mL sumatriptan
Dosage Form: Nasal spray solution
NZ Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome SpA, San Polo di Torrile, Parma, Italy
Product: Pain Relief Tablets
Active Ingredient(s): Paracetamol 500mg
Dosage Form: Tablet
NZ Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, AUCKLAND
Product: Puregon
Active Ingredient(s): Follitropin beta 833IU/mL equivalent to 300IU in 0.36mL
Dosage Form: Solution for injection
NZ Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Puregon
Active Ingredient(s): Follitropin beta 833IU/mL equivalent to 600IU in 0.72mL
Dosage Form: Solution for injection
NZ Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Stemetil
Active Ingredient(s): Prochlorperazine maleate 25mg
Dosage Form: Suppository
NZ Sponsor: Aventis Pharma Limited
Manufacturer(s): Rhone-Poulenc Rorer Natrapharm (Ireland) Limited, Waterford, Ireland
Product: Stemetil
Active Ingredient(s): Prochlorperazine maleate 5mg
Dosage Form: Suppository
NZ Sponsor: Aventis Pharma Limited
Manufacturer(s): Rhone-Poulenc Rorer Natrapharm (Ireland) Limited, Waterford, Ireland
Dated this 8th day of March 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).