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: Cetirizine-AFT
Active Ingredient: Cetirizine hydrochloride 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Product: Coldrex PE Phenylephrine Cold & Flu Plus
Active Ingredients: Caffeine 25mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland
Product: Durex Performa
Active Ingredient: Benzocaine 1.3%
Dosage Form: Medicated condom
New Zealand Sponsor: SSL New Zealand Limited
Manufacturer: SSL Healthcare Manufacturing S A, Avenida Can Fatjo Isi, Barcelona, Spain
Product: Panadol Cold & Flu Hot Lemon
Active Ingredient: Paracetamol 600mg
Dosage Form: Powder
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham SA, Ctra. de Ajalvir, Alcala de Henares (Madrid), Spain
Product: Terbinafine Cream
Active Ingredient: Terbinafine hydrochloride 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: SFY Limited
Manufacturer: Cipla Limited, District Raigad, (Maharashtra), India
Product: Xolair
Active Ingredient: Omalizumab 75mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturers: Genentech Inc, South San Francisco, California, United States of America
Novartis Pharma Stein AG, Stein, Switzerland
Dated this 30th day of November 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).