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: Aquamid
Active Ingredient: Polyacrylamide 25mg/g
Dosage Form: Gel for injection
New Zealand Sponsor: Clinical and Regulatory Services Limited
Manufacturer: Ferrosan A/S, Soborg, Denmark
Product: Arrow – Roxithromycin 150
Active Ingredient: Roxithromycin 150mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
Product: Arrow – Roxithromycin 300
Active Ingredient: Roxithromycin 300mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
Product: Arrow – Sumatriptan
Active Ingredient: Sumatriptan succinate 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada
Product: Arrow – Sumatriptan
Active Ingredient: Sumatriptan succinate 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada
Product: DP-Cipro
Active Ingredient: Ciprofloxacin 200mg
Dosage Form: Solution for infusion
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Hikma Farmaceutica (Portugal) Lda, Fervenca, Terrugem - Sintra, Portugal
Product: Estalis Sequi
Active Ingredient: Oestradiol hemihydrate 0.78mg equivalent to 50µg/24 hours
Dosage Form: Phase I patch Transdermal patch
Active Ingredients: Norethisterone acetate 2.7mg equivalent to 140µg/24 hours
Oestradiol hemihydrate 0.62mg equivalent to 50µg/24 hours
Phase II patch 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 0.78mg equivalent to 50µg/24 hours
Dosage Form: Phase I Transdermal patch
Active Ingredients: Norethisterone acetate 4.8mg equivalent to 250µg/24 hours
Oestradiol hemihydrate 0.512mg equivalent to 50µg/24 hours
Phase II Transdermal patch
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Noven Pharmaceuticals Inc, Miami, Florida, United States of America
Product: Gastro-Soothe
Active Ingredient: Hyoscine butylbromide 10mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Matrix Laboratories Limited, Sinnar, Nashik, Maharashta, India
Product: Genteal Gel
Active Ingredients: Carbomer 980 2mg/g
Hypromellose 3mg/g
Dosage Form: Ophthalmic gel
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Excelvision AG, Hettlingen, Switzerland
Product: Itrazole
Active Ingredient: Itraconazole 100mg
Dosage Form: Capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Martec Scientific Inc, Kansas City, Missouri, United States of America
Product: Logem
Active Ingredient: Lamotrigine 100mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Product: Logem
Active Ingredient: Lamotrigine 200mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Product: Logem
Active Ingredient: Lamotrigine 25mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Product: Logem
Active Ingredient: Lamotrigine 50mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Product: Sodium Cromoglycate Eye Drops
Active Ingredient: Sodium cromoglicate 2%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
Product: Vivotif Oral
Active Ingredient: Salmonella typhi strain TY21A Berna 2,000 million organisms
Dosage Form: Modified release capsule
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: Berna Biotech AG, Berne, Switzerland
Dated this 22nd day of September 2006.
GRAEME GILLESPIE, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).