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: Amiodarone Hydrochloride Injection Concentrate
Active Ingredient(s): Amiodarone hydrochloride 50mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Faulding Puerto Rico Inc, Ramey Branch, Aguadilla, Puerto Rico
Product: Athruderm
Active Ingredient(s): Diclofenac sodium 10.8mg/g equivalent to 1% diclofenac
Dosage Form: Lotion
New Zealand Sponsor: Trans Dermal Pharmaceuticals (NZ) Limited
Manufacturer(s): Divpharm Manufacturing and Packaging Co, Longdale, Johannesburg, South Africa
Product: Codeine Phosphate Injection USP
Active Ingredient(s): Codeine phosphate (hemihydrate) 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Iopamiro 150
Active Ingredient(s): Iopamidol 30.62%w/v equivalent 150mg/ml iodine
Dosage Form: Solution for injection
New Zealand Sponsor: Regional Health Limited
Manufacturer(s): Bracco SpA., Milano, Italy
Product: Nitromint
Active Ingredient(s): Glyceryl trinitrate 0.4mg/dose
Dosage Form: Sublingual spray
New Zealand Sponsor: Servier Laboratories Limited
Manufacturer(s): Egis Pharmaceuticals Limited., Egis Lacta Factory, Kormend, Hungary
Dated this 30th day of August 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).