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: Asacol
Active Ingredient: Mesalazine 800mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Haupt Pharma Wulfing GmbH, Gronau, Germany
Product: Ethics Numbing Throat Lozenges
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Lidocaine hydrochloride 10mg
Dosage Form: Lozenge
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Himachal Pradesh, India
Product: Ethics Soothing Throat Lozenges
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Himachal Pradesh, India
Product: Mycophenolate Sandoz
Active Ingredient: Mycophenolate mofetil 250mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Private Limited, Navi Mumbai, India
Product: Mycophenolate Sandoz
Active Ingredient: Mycophenolate mofetil 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Private Limited, Navi Mumbai, India
Product: Salinaax Eye Wash
Active Ingredients: Monobasic potassium phosphate 6.8mg
Sodium chloride 5.7mg
Dosage Form: Eye irrigation
New Zealand Sponsor: Tollot Pty Limited t/a Aaxis Pacific
Manufacturer: OPTO PHARMA Pte Limited, Singapore
Dated this 12th day of September 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).