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: FerroTab
Active Ingredient: Ferrous fumarate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Remedica Limited, Limassol, Cyprus
Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, District Raigad, (Maharashtra), India
Product: MDS QuickCup One-Step Pregnancy Test
Active Ingredients: Bovine serum albumin 0.7µg
Goat anti-alpha-hCG polyclonal antibody 1.4µg
Goat anti-mouse polyclonal antibody 3.5µg
Murine anti-beta-hCG monoclonal antibody-colloidal gold conjugate 1.4µg
Dosage Form: Pregnancy test kit
New Zealand Sponsor: MDS Diagnostics Limited
Manufacturer: Phamatech, San Diego, California, United States of America
Product: Nurofen Tension Headache
Active Ingredient: Ibuprofen lysinate 342mg equivalent to 200mg ibuprofen
Dosage Form: Film coated tablet
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer: The Boots Company Plc., Beeston, Nottingham, Nottinghamshire, United Kingdom
Product: Rapid Restore Gastro Pack (Combination Product)
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Tablet
Manufacturer: Cipla Limited, Manufacturing Division, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Active Ingredients: Glucose monohydrate 72.65%w/w
Potassium chloride 6.12%w/w
Sodium acid citrate 10.82%w/w
Sodium chloride 9.59%w/w
Dosage Form: Powder for oral solution
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
New Zealand Sponsor: Multichem NZ Limited
Product: Sensodyne Fresh Impact
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, Consumer Healthcare, Ermington, New South Wales, Australia
Product: Strepsils Orange (improved flavour)
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer: The Boots Company Plc., Beeston, Nottingham, Nottinghamshire, United Kingdom
Dated this 26th day of September 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).