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: alli
Active Ingredient: Orlistat 60mg
Dosage Form: Capsule
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Consumer Healthcare LP, Aiken, United States of America
Product: Azocin 500 mg
Active Ingredient: Azithromycin monohydrate 512mg equivalent to 500mg azithromycin
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Sandoz SrL, Targu Mures, Romania
Product: Fluconazole
Active Ingredient: Fluconazole 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare of Puerto Rico, Jayuya, Puerto Rico
Product: Jurnista
Active Ingredient: Hydromorphone hydrochloride 4mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, United States of America
Product: Sensodyne Pronamel
Active Ingredients: Potassium nitrate 50mg/g
Sodium fluoride 2.21mg/g
Dosage Form: Toothpaste
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Dated this 3rd day of June 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).