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: Acnederm Foaming Wash
Active Ingredient(s): Cetrimide 1%w/w
Chlorhexidine gluconate 0.5%w/w
Dosage Form: Topical solution
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia
Product: Chesty Mucus Cough
Active Ingredient(s): Ammonium chloride 25mg/mL
Diphenhydramine hydrochloride 2.5mg/mL
Sodium citrate (dihydrate) 10mg/mL
Dosage Form: Syrup
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, Auckland
Product: DermAid 1%
Active Ingredient(s): Hydrocortisone 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia
Product: femhrt
Active Ingredient(s): Ethinyloestradiol 10µg
Norethisterone acetate 1mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Duramed Pharmaceuticals Inc, Cincinnati, Ohio, United States of America
Product: femhrt
Active Ingredient(s): Ethinyloestradiol 5µg
Norethisterone acetate 1mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Duramed Pharmaceuticals Inc, Cincinnati, Ohio, United States of America
Product: Solian 100
Active Ingredient(s): Amisulpride 100mg
Dosage Form: Tablet
New Zealand Sponsor: Sanofi-Synthelabo (NZ) Limited
Manufacturer(s): Sanofi Winthrop Industrie, Quetigny, France
Product: Solian 200
Active Ingredient(s): Amisulpride 200mg
Dosage Form: Tablet
New Zealand Sponsor: Sanofi-Synthelabo (NZ) Limited
Manufacturer(s): Sanofi Winthrop Industrie, Quetigny, France
Product: Solian 400
Active Ingredient(s): Amisulpride 400mg
Dosage Form: Tablet
New Zealand Sponsor: Sanofi-Synthelabo (NZ) Limited
Manufacturer(s): Sanofi Winthrop Industrie, Quetigny, France
Product: Solian 50
Active Ingredient(s): Amisulpride 50mg
Dosage Form: Tablet
New Zealand Sponsor: Sanofi-Synthelabo (NZ) Limited
Manufacturer(s): Sanofi Winthrop Industrie, Quetigny, France
Product: Structolipid 20%
Active Ingredient(s): Triglycerides (purified structured) 200g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer(s): Fresenius Kabi AB, Uppsala, Sweden
Dated this 6th day of September 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).