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: BeneFIX
Active Ingredient: Nonacog alfa 2,000IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Farma S.A., Ctra de Madrid-Burgos, San Sebastian de los Reyes, Madrid, Spain
Product: Cetirizine Syrup
Active Ingredient: Cetirizine hydrochloride 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Mediorals Laboratories Pvt Limited, Satara, Maharashtra, India
Product: Lamivudine
Active Ingredient: Lamivudine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Verna Industrial Area, Salcette, Goa, India
Product: Mitozantrone Ebewe
Active Ingredient: Mitoxantrone hydrochloride 2.3284mg/mL equivalent to mitoxantrone 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Product: Vicks Cough Lozenge with Honey for Dry Cough
Active Ingredient: Dextromethorphan 7.34mg
Dosage Form: Lozenge
New Zealand Sponsor: Procter & Gamble Distributing New Zealand
Manufacturer: Procter & Gamble GmbH, Gross Gerau, Germany
Product: Zobacin
Active Ingredients: Piperacillin sodium 2.085g equivalent to 2.000g piperacillin
Tazobactam sodium 268.3mg equivalent to 250mg tazobactam
Dosage Form: Powder for injection
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Laboratorio Farmaceutico CT SrL, San Remo (IM), Italy
Product: Zobacin
Active Ingredients: Piperacillin sodium 4.170g equivalent to 4.000g piperacillin
Tazobactam sodium 536.6mg equivalent to 500mg tazobactam
Dosage Form: Powder for injection
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Laboratorio Farmaceutico CT SrL, San Remo (IM), Italy
Dated this 27th day of September 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).