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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Lantus
Insulin glargine 100IU/mL
Solution for injection
Sanofi-Aventis New Zealand Limited
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Nitroderm TTS 5
Glyceryl trinitrate 25mg
Transdermal patch
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
LTS Lohmann Therapie-Systeme AG, Andernach, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Nitroderm TTS 10
Glyceryl trinitrate 50mg
Transdermal patch
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
LTS Lohmann Therapie-Systeme AG, Andernach, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Orencia
Abatacept 125mg
Solution for injection
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma LLC, Manati, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Orencia
Abatacept 262.5mg
Powder for injection
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma LLC, Manati, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Rabipur
Rabies vaccine 2.5IU
Powder for injection
GlaxoSmithKline (NZ) Limited
GSK Vaccines GmbH, Marburg, Germany
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Dated this 9th day of November 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