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: Levonelle-1
Active Ingredient: Levonorgestrel 1.5mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Gedeon Richter Ltd, Budapest, Hungary
Product: Onsetron
Active Ingredient: Ondansetron hydrochloride dihydrate 2.5mg/mL equivalent to ondansetron 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Onsetron
Active Ingredient: Ondansetron hydrochloride dihydrate 5mg equivalent to ondansetron 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Onsetron
Active Ingredient: Ondansetron hydrochloride dihydrate 10mg equivalent to ondansetron 8mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Postinor-1
Active Ingredient: Levonorgestrel 1.5mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Gedeon Richter Ltd, Budapest, Hungary
Dated this 5th day of April 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).