Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:
Schedule
Product: Keppra
Active Ingredient: Levetiracetam 1,000mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Wyber Debra
Manufacturer: UCB SA, Pharmaceutical Sector, Braine-l’Alleud, Brussels, Belgium
Product: Keppra
Active Ingredient: Levetiracetam 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Wyber Debra
Manufacturer: UCB SA, Pharmaceutical Sector, Braine-l’Alleud, Brussels, Belgium
Product: Keppra
Active Ingredient: Levetiracetam 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Wyber Debra
Manufacturer: UCB SA, Pharmaceutical Sector, Braine-l’Alleud, Brussels, Belgium
Product: Keppra
Active Ingredient: Levetiracetam 750mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Wyber Debra
Manufacturer: UCB SA, Pharmaceutical Sector, Braine-l’Alleud, Brussels, Belgium
Dated this 15th day of March 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).