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: LevophedT 1:1000
Active Ingredient: Noradrenaline acid tartrate monohydrate 2mg/mL equivalent to Noradrenaline base 1mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Inc, Kansas, United States of America
Product: Minax XL
Active Ingredient: Metoprolol succinate 23.75mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Minax XL
Active Ingredient: Metoprolol succinate 47.5mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Minax XL
Active Ingredient: Metoprolol succinate 95mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Minax XL
Active Ingredient: Metoprolol succinate 190mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Sodium Chloride Injection BP 0.9%
Active Ingredient: Sodium chloride 0.9%
Dosage Form: Solution for injection
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi Espana S.A.U, Barcelona, Spain
Dated this 11th day of September 2014.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).