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
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Product:
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Ardanest 4% with adrenaline (epinephrine) 1:100,000
Adrenaline acid tartrate 0.018mg/mL
equivalent to adrenaline (epinephrine) base 0.01 mg/mL
Articaine hydrochloride 40mg/mL
Solution for injection
HealthCare Essentials Limited
Laboratorios INIBSA, Barcelona, Spain
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Product:
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New Zealand Sponsor:
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Ardanest 4% with adrenaline (epinephrine) 1:200,000
Adrenaline acid tartrate 0.009mg/mL
equivalent to adrenaline (epinephrine) base 0.005 mg/mL
Articaine hydrochloride 40mg/mL
Solution for injection
HealthCare Essentials Limited
Laboratorios INIBSA, Barcelona, Spain
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Product:
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Levodopa and Carbidopa CR Actavis
Carbidopa 50mg
Levodopa 200mg
Modified release tablet
Actavis New Zealand Limited
Intas Pharmaceuticals Limited, Gujarat, India
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Product:
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Urchol
Ursodeoxycholic acid 250mg
Capsule
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Strides Arcolab Limited, Bangalore, India
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Dated this 4th day of September 2015.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz