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: Octagam
Active Ingredient: Normal immunoglobulin 50mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: Octapharma AB, Stockholm, Sweden
Octapharma Pharmazeutika Productionsges, Vienna, Austria
Octapharma, Lingolsheim, France
Product: Tamsil
Active Ingredient: Terbinafine hydrochloride 10mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Arrow Pharmaceuticals New Zealand Limited
Manufacturer: Gedeon Richter Limited, Budapest, Hungary
Product: Xergic
Active Ingredient: Fexofenadine hydrochloride 120mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Product: Xergic
Active Ingredient: Fexofenadine hydrochloride 180mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Product: Xergic
Active Ingredient: Fexofenadine hydrochloride 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Product: Xergic
Active Ingredient: Fexofenadine hydrochloride 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Product: Zaditen
Active Ingredient: Ketotifen fumarate 345µg/mL equivalent to ketotifen 250µg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Excelvision, Rue de la Lombardiere, Annonay Cedex, France
Dated this 9th day of June 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).