Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Berocca Performance
Active Ingredients: Ascorbic acid 500mg
Biotin 0.15mg
Calcium carbonate 243.974mg equivalent to calcium 97.69mg
Calcium pantothenate 25mg
Cyanocobalamin 0.01mg
Folic acid 0.4mg
Heavy magnesium carbonate 194.822mg equivalent to magnesium 49mg
Magnesium sulphate dihydrate 328.2mg equivalent to magnesium 51mg
Monophosphothiamine 18.54mg equivalent to thiamine hydrochloride anhydrous 15mg
Nicotinamide 50mg
Pyridoxine hydrochloride 10mg
Riboflavin sodium phosphate 20.51mg equivalent to riboflavine 15mg
Zinc citrate 32.041mg
Dosage Form: Effervescent tablet
New Zealand Sponsor: Roche Consumer Health, Division of Roche Products (New Zealand) Limited
Manufacturer: Roche Products Pty Limited, Dee Why, New South Wales, Australia
Product: Clean & Clear Invisible Blemish Treatment Gel
Active Ingredients: Alcohol 27.9%w/w
Salicylic acid 2%w/w
Dosage Form: Topical gel
New Zealand Sponsor: Johnson & Johnson Pacific New Zealand, Division of Johnson & Johnson (NZ) Limited
Manufacturer: Milpharma Pty Limited, Brookvale, New South Wales, Australia
Product: Clomazol
Active Ingredient: Clotrimazole 10mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Patalganga, District Raigad, Maharashtra, India
Product: Clomazol
Active Ingredient: Clotrimazole 10mg/g
Dosage Form: Vaginal cream
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Ltd, Patalganga, District Raigad, Maharashtra, India
Product: Ketopine 2%
Active Ingredient: Ketoconazole 2%w/w
Dosage Form: Shampoo
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Product: Otrisal
Active Ingredient: Sodium chloride 0.74%w/w
Dosage Form: Nasal spray solution
New Zealand Sponsor: Novartis Consumer Health Australasia Pty. Limited.
Manufacturer: Novartis Consumer Health SA, Prangins, Nyon, Switzerland
Dated this 26th day of September 2003.
GRAEME GILLESPIE, Manager, Public Health Programmes, acting as Deputy Director-General, Public Health, for the period 24 September 2003 to 26 September 2003 (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).