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: Arrow – Norfloxacin
Active Ingredient: Norfloxacin 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Sigma Pharmaceuticals Pty Limited, Baulkham Hills, New South Wales, Australia
Product: Difflam Forte Anti-Inflammatory Throat Spray
Active Ingredient: Benzydamine hydrochloride 3mg/mL
Dosage Form: Oral spray
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: Aziende Chimiche Riunite Angelini Francesco SpA, Ancona, Italy
Product: Estalis Continuous
Active Ingredients: Norethisterone acetate 2.4mg equivalent to norethisterone acetate 125 µg/24 hours
Oestradiol hemihydrate 0.256mg equivalent to estradiol 25 µg/24 hours
Dosage Form: Transdermal patch
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Noven Pharmaceuticals Inc, Miami, Florida, United States of America
Product: Estalis Continuous
Active Ingredients: Norethisterone acetate 2.7mg equivalent to norethisterone acetate 140 µg/24 hours
Oestradiol hemihydrate 0.62mg equivalent to oestradiol 50 µg/24 hours
Dosage Form: Transdermal patch
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Noven Pharmaceuticals Inc, Miami, Florida, United States of America
Product: Estalis Continuous
Active Ingredients: Norethisterone acetate 4.8mg equivalent to norethisterone acetate 250 µg/24 hours
Oestradiol hemihydrate 0.512mg equivalent to oestradiol 50 µg/24 hours
Dosage Form: Transdermal patch
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Noven Pharmaceuticals Inc, Miami, Florida, United States of America
Product: Estalis Sequi
Active Ingredient: Oestradiol 4.33mg equivalent to 50 µg/24h oestradiol
Dosage Form: Phase I – Menorest component Transdermal patch
Active Ingredients: Norethisterone acetate 2.7mg equivalent to norethisterone acetate 140 µg/24 hours
Oestradiol hemihydrate 0.62mg equivalent to oestradiol 50 µg/24 hours
Dosage Form: Phase II – Estalis component Transdermal patch
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Noven Pharmaceuticals Inc, Miami, Florida, United States of America
Product: Estalis Sequi
Active Ingredient: Oestradiol hemihydrate 4.33mg equivalent to oestradiol 50 µg/24 hours
Dosage Form: Phase I – Menorest component Transdermal patch
Active Ingredients: Norethisterone acetate 4.8mg equivalent to norethisterone acetate 250 µg/24 hours
Oestradiol hemihydrate 0.512mg equivalent to oestradiol 50 µg/24 hours
Dosage Form: Phase II – Estalis component Transdermal patch
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Noven Pharmaceuticals Inc, Miami, Florida, United States of America
Product: Vaxigrip Junior
Active Ingredients: Influenza virus A/Wellington/I/2004(H3N2)-like strain 7.5µg/dose
Influenza virus B/Shanghai/361/2002-like strain 7.5µg/dose
Influenza virus haemagglutin type A/New Caledonia/20/99 H1N1-like strain 7.5µg/dose
Dosage Form: Solution for injection
New Zealand Sponsor: Aventis Pharma Limited
Manufacturers: Aventis Pasteur SA, 1541 Avenue Marcel Merieux, Marcy L’Etoile, France
Aventis Pasteur SA, Parc Industrial d’Incarville, Val-De-Reuil Cedex, France
Dated this 3rd day of October 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).