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: Apo-Prazo
Active Ingredient(s): Prazosin hydrochloride 1.1mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Note: Not interchangeable with Pratsiol.
Product: Apo-Prazo
Active Ingredient(s): Prazosin hydrochloride 2.2mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Note: Not interchangeable with Pratsiol.
Product: Apo-Prazo
Active Ingredient(s): Prazosin hydrochloride 5.5mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Note: Not interchangeable with Pratsiol.
Product: Colgate Neutrafluor 220 Daily Fluoride Mouth Rinse
Active Ingredient(s): Sodium fluoride 0.05%w/v equivalent to 220ppm fluoride ion
Dosage Form: Mouthwash
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer(s): Colgate Oral Pharmaceuticals, Texas, United States of America
Product: Elosalic
Active Ingredient(s): Mometasone furoate 1mg/g
Salicylic acid 50mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Inc, Kenilworth, New Jersey, United States of America
Product: Metalyse
Active Ingredient(s): Tenecteplase 30mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer(s): Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Product: Metalyse
Active Ingredient(s): Tenecteplase 40mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer(s): Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Product: Metalyse
Active Ingredient(s): Tenecteplase 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer(s): Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Product: Pacific Cefaclor 125
Active Ingredient(s): Cefaclor (monohydrate) 26.22mg/mL equivalent to 25mg/mL cefaclor
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Merck Farma y Quimica SA, Poligono Merck, Mollet del Valles, Barcelona, Spain
Product: Pacific Cefaclor 250
Active Ingredient(s): Cefaclor (monohydrate) 52.45mg/mL equivalent to 50mg/mL cefaclor
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Merck Farma y Quimica SA, Poligono Merck, Mollet del Valles, Barcelona, Spain
Product: Panadol Gel Tabs
Active Ingredient(s): Paracetamol 500mg/dose
Dosage Form: Coated tablet
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): Banner Pharmacaps Inc, Chatsworth, California 91311, United States of America
SmithKline Beecham (Australia) Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia
SmithKline Beecham (Dungarvan) Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland
Dated this 7th day of May 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).