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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Diclax SR
Diclofenac sodium 75mg
Modified release tablet
Douglas Pharmaceuticals Limited
Valpharma S.p.A., Serravalle, San Marino
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Diclax SR
Diclofenac sodium 100mg
Modified release tablet
Douglas Pharmaceuticals Limited
Valpharma S.p.A., Serravalle, San Marino
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Privigen
Normal immunoglobulin 100g/L
Solution for infusion
CSL Behring (NZ) Limited
CSL Behring AG, Bern, Switzerland
CSL Behring (Australia) Pty Limited, Melbourne, Australia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Zaditen (Preserved formulation)
Ketotifen fumarate 345mcg/mL equivalent to ketotifen 250mcg/mL
Eye drops, solution
Novartis New Zealand Limited
Excelvision, Annonay, France
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Zaditen (Unpreserved formulation)
Ketotifen fumarate 345mcg/mL equivalent to ketotifen 250mcg/mL
Eye drops, solution
Novartis New Zealand Limited
Excelvision, Annonay, France
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Dated this 5th day of June 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz