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-Clopidogrel
Active Ingredient: Clopidogrel bisulfate 98mg equivalent to 75mg clopidogrel
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturers: Apotex Inc, Weston, Ontario, Canada
Apotex Inc, Etobicoke, Ontario, Canada
Product: Keppra
Active Ingredient: Levetiracetam 1000mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Wyber Debra
Manufacturers: UCB Farchim SA, Zone Industrial de Planchy, Bulle, Switzerland
UCB Pharma SA, Chemin du Foriest, Braine-l’Alleud, Belgium
Product: Keppra
Active Ingredient: Levetiracetam 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Wyber Debra
Manufacturers: UCB Farchim SA, Zone Industrial de Planchy, Bulle, Switzerland
UCB Pharma SA, Chemin du Foriest, Braine-l’Alleud, Belgium
Product: Keppra
Active Ingredient: Levetiracetam 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Wyber Debra
Manufacturers: UCB Farchim SA, Zone Industrial de Planchy, Bulle, Switzerland
UCB Pharma SA, Chemin du Foriest, Braine-l’Alleud, Belgium
Product: Keppra
Active Ingredient: Levetiracetam 750mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Wyber Debra
Manufacturers: UCB Farchim SA, Zone Industrial de Planchy, Bulle, Switzerland
UCB Pharma SA, Chemin du Foriest, Braine-l’Alleud, Belgium
Product: Moviprep
(Satchet A)
Active Ingredients: Macrogol 3350 100g
Potassium chloride 1.015g
Sodium chloride 2.691g
Sodium sulfate 7.5g
Dosage Form: Powder for oral solution
(Satchet B)
Active Ingredients: Ascorbic acid 4.7g
Sodium ascorbate 5.9g
Dosage Form: Powder for oral solution
New Zealand Sponsor: Clinical and Regulatory Services Limited
Manufacturer: Norgine Limited, Tir-y-berth, Hengoed, Mid Glamorgan, United Kingdom
Dated this 20th day of May 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).