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: Aquaear drops
Active Ingredient(s): Glacial acetic acid 17.3mg/mL
Isopropyl alcohol 634mg/mL
Dosage Form: Ear drops
New Zealand Sponsor: Whitehall Consumer Healthcare (NZ) Limited
Manufacturer(s): Ensign Laboratories Pty Limited, Mulgrave, Victoria, Australia
Product: Aridine
Active Ingredient(s): Loratadine 10mg/dose
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Delta Limited, Hafnarfjordur, Iceland
Product: Ceftriaxone
Active Ingredient(s): Ceftriaxone sodium 1,193.3mg equivalent to 1000mg ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Ceftriaxone
Active Ingredient(s): Ceftriaxone sodium 2,386.6mg equivalent to 2000mg ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Ceftriaxone
Active Ingredient(s): Ceftriaxone sodium 298.3mg equivalent to 250mg ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Ceftriaxone
Active Ingredient(s): Ceftriaxone sodium 596.7mg equivalent to 500mg ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Chesty Congested Cough
Active Ingredient(s): Opium tincture 16.08mg/mL
Squill oxymel 44.4mg/mL
Dosage Form: Linctus
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, Auckland
Product: Dry Irritating Cough
Active Ingredient(s): Dextromethorphan hydrobromide 1mg/mL
Dosage Form: Syrup
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, Auckland
Product: FungoCort 0.5%
Active Ingredient(s): Hydrocortisone 0.525%w/w
Miconazole nitrate 2%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Ego Pharmaceuticals Pty Lmited, Braeside, Victoria, Australia
Product: Kiddies Dry Tickly Cough
Active Ingredient(s): Pholcodine 1mg/mL
Dosage Form: Linctus
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, Auckland
Product: Pepzan
Active Ingredient(s): Famotidine 20mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Douglas Pharmaceuticals Limited, Lincoln, Auckland
Product: Phenoxymethylpenicillin Oral Solution
Active Ingredient(s): Phenoxymethylpenicillin potassium 27.718mg/mL equivalent to 25mg/mL phenoxymethylpenicillin
Dosage Form: Granules for oral solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Athlone Laboratories Limited, Ballymurray, County Roscommon, Ireland
Product: Phenoxymethylpenicillin Oral Solution
Active Ingredient(s): Phenoxymethylpenicillin potassium 55.636mg/mL equivalent to 50mg/mL phenoxymethylpenicillin
Dosage Form: Granules for oral solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Athlone Laboratories Limited, Ballymurray, County Roscommon, Ireland
Product: Stubborn Dry Tickly Cough
Active Ingredient(s): Pholcodine 2mg/mL
Dosage Form: Linctus
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, Auckland
Product: Trileptal
Active Ingredient(s): Oxcarbazepine 60mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma SA, Huningue, France
Product: Videx (mandarin orange flavour)
Active Ingredient(s): Didanosine 200mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Dated this 5th day of June 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).