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-Paroxetine
Active Ingredient: Paroxetine hydrochloride 22.2mg equivalent to 20mg paroxetine base
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Calcium Folinate Ebewe
Active Ingredient: Calcium folinate pentahydrate 12.71mg/mL equivalent to 10mg/mL folinic acid
Dosage Form: Concentrate for injection
New Zealand Sponsor: InterPharma Pty Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Product: Fuzeon
Active Ingredient: Enfuvirtide 108mg
Dosage Form: Powder for injection
Active Ingredient: Water for injection
Dosage Form: Diluent
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche AG, Basel, Switzerland
Pfizer Inc, Kalamazoo, Michigan, United States of America
Roche Diagnostics GmbH, Mannheim, Germany
Product: Motrig
Active Ingredient: Lamotrigine 100mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Product: Motrig
Active Ingredient: Lamotrigine 200mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Product: Motrig
Active Ingredient: Lamotrigine 25mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Product: Motrig
Active Ingredient: Lamotrigine 50mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Product: Rennie
Active Ingredients: Calcium carbonate 680mg
Heavy magnesium carbonate 80mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Laboratoires Roche Nicholas SA, Gaillard, France
Product: Reyataz
Active Ingredient: Atazanavir sulfate 113.9mg equiv to 100mg atazanavir
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Product: Reyataz
Active Ingredient: Atazanavir sulfate 170.84mg equiv to 150mg atazanavir
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Product: Reyataz
Active Ingredient: Atazanavir sulfate 227.79mg equiv to 200mg atazanavir
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Dated this 9th day of March 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).