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: APO-Osteo Paracetamol 665 mg
Active Ingredient: Paracetamol 665mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Rubicon Research Pvt. Limited, Mumbai, India
Product: APO-Paracetamol XR 665 mg
Active Ingredient: Paracetamol 665mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Rubicon Research Pvt. Limited, Mumbai, India
Product: Clarithromycin 500 mg Powder for Concentrate for Solution for Infusion
Active Ingredient: Clarithromycin 500mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Max Health Limited
Manufacturer: Laboratorios Alcala Farma S.L., Madrid, Spain
Product: Paracetamol XR 665 mg
Active Ingredient: Paracetamol 665mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Rubicon Research Pvt. Limited, Mumbai, India
Product: Riodine Povidone-Iodine Concentrated Gargle
Active Ingredient: Povidone-iodine 75mg/mL equivalent to 0.75% w/v iodine
Dosage Form: Mouthwash
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited t/a Perrigo Australia, Balcatta, Australia
Dated this 18th day of September 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).