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® Piperacillin and Tazobactam
Active Ingredients: Piperacillin 2g
Tazobactam 0.25g
Dosage Form: Powder for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturer: Orchid Chemicals and Pharmaceuticals Limited, Kancheepuram District, India
Product: DBL® Piperacillin and Tazobactam
Active Ingredients: Piperacillin 4g
Tazobactam 0.5g
Dosage Form: Powder for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturer: Orchid Chemicals and Pharmaceuticals Limited, Kancheepuram District, India
Product: DBL® Ciprofloxacin Injection for Intravenous Infusion
Active Ingredient: Ciprofloxacin 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturer: Biomendi S.A., Bernedo (Alava), Spain
Product: Ondansetron Sandoz
Active Ingredient: Ondansetron hydrochloride dihydrate 2.5mg/mL equivalent to 2mg/mL ondansetron base
Dosage Form: Solution for injection
New Zealand Sponsor: Sandoz New Zealand, Novartis New Zealand Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Orgalutran
Active Ingredient: Ganirelix 0.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Dated this 19th day of July 2007.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).