13 OCTOBER 2005

NEW ZEALAND GAZETTE, No. 175

4405

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:
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/1/2004(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).