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: DBL® Clindamycin
Active Ingredient: Clindamycin phosphate 356.46mg equivalent to Clindamycin 300mg
Dosage Form: Solution for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Product: DBL® Clindamycin
Active Ingredient: Clindamycin phosphate 712.92mg equivalent to Clindamycin 600mg
Dosage Form: Solution for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Product: Lantus SoloStar
Active Ingredient: Insulin glargine 3.6378mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
Product: Strepsils Dry Cough Extra Strength
Active Ingredient: Dextromethorphan hydrobromide, anhydrous 15mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Bangplee, Samutprakarn, Thailand
Dated this 17th day of May 2007.
KAREN MITCHELL, Acting-Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).