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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Pamisol™
Pamidronic acid 2.53mg/mL equivalent to pamidronate disodium 3mg/mL
Concentrate for injection
Hospira NZ Limited
Hospira Australia Pty Limited, Melbourne, Australia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Pamisol™
Pamidronic acid 5.05mg/mL equivalent to pamidronate disodium 6mg/mL
Concentrate for injection
Hospira NZ Limited
Hospira Australia Pty Limited, Melbourne, Australia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Pamisol™
Pamidronic acid 7.58mg/mL equivalent to pamidronate disodium 9mg/mL
Concentrate for injection
Hospira NZ Limited
Hospira Australia Pty Limited, Melbourne, Australia
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Triumeq
Abacavir sulfate 702mg equivalent to abacavir 600mg
Dolutegravir sodium 52.6mg equivalent to dolutegravir 50mg
Lamivudine 300mg
Film coated tablet
Sponser Name
GlaxoSmithKline (NZ) Limited
Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
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Dated this 25th day of February 2016.
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