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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Metaraminol
Metaraminol tartrate 19mg/mL equivalent to metaraminol base 10mg/mL
Solution for injection
Max Health Limited
Torbay and South Devon NHS Foundation Trust, Paignton, United Kingdom
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Omeprazole Infusion 40mg
Omeprazole 40mg
Powder for infusion
Dr Reddy’s New Zealand Limited
Sofarimex Industria Quimica e Farmaceutica Lda, Agualva, Portugal
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Omeprazole Injection 40mg
Omeprazole sodium 42.6mg equivalent to omeprazole base 40mg
Powder for injection
Dr Reddy’s New Zealand Limited
Sofarimex Industria Quimica e Farmaceutica Lda, Agualva, Portugal
Laboratorios Alcala Farma S.L., Madrid, Spain
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Sandomigran
Pizotifen malate 0.725mg equivalent to Pizotifen 0.5mg
Tablet
AFT Pharmaceuticals Limited
Labiana Pharmaceuticals SL, Barcelona, Spain
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Dated this 25th day of March 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz