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: Ciloxan Eye Ointment
Active Ingredient: Ciprofloxacin hydrochloride 3.5mg/g equivalent to anhydrous ciprofloxacin base 3mg/g
Dosage Form: Eye ointment
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium
Product: Concerta
Active Ingredient: Methylphenidate hydrochloride 27mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America
Product: Nurofen Rapid (Pharmacy Only)
Active Ingredient: Ibuprofen lysinate 342mg equivalent to 200mg Ibuprofen
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Nurofen Rapid (General Sale)
Active Ingredient: Ibuprofen lysinate 342mg equivalent to 200mg Ibuprofen
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Strepsils Sore Throat & Blocked Nose
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Menthol 8mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Bangplee, Samutprakarn, Thailand
Dated this 23rd day of November 2007.
JULIE PATTERSON, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).