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:
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New Zealand Sponsor:
Manufacturer:
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Giotrif
Afatinib dimaleate 29.56mg equivalent to afatinib 20mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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Product:
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Dosage Form:
New Zealand Sponsor:
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Giotrif
Afatinib dimaleate 44.34mg equivalent to afatinib 30mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
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Giotrif
Afatinib dimaleate 59.12mg equivalent to afatinib 40mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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Product:
Active Ingredient:
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New Zealand Sponsor:
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Giotrif
Afatinib dimaleate 73.9mg equivalent to afatinib 50mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
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Prednisolone-AFT
Prednisolone acetate 10mg/mL
Eye drops, suspension
AFT Pharmaceuticals Limited
Ursapharm Arzneimittel GmbH, Saarbrucken, Germany
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Note: Additional active ingredient manufacturing site as described in the application received 17 November 2016.
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Product:
Active Ingredient:
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New Zealand Sponsor:
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Prednisolone-AFT
Prednisolone acetate 10mg/mL
Eye drops, suspension
AFT Pharmaceuticals Limited
Ursapharm Arzneimittel GmbH, Saarbrucken, Germany
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Note: Increased finished product manufacturing scale as described in application received 17 November 2016.
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Product:
Active Ingredients:
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Synflorix
Pneumococcal polysaccharide type 1 1mcg
Pneumococcal polysaccharide type 14 1mcg
Pneumococcal polysaccharide type 18C 3mcg
Pneumococcal polysaccharide type 19F 3mcg
Pneumococcal polysaccharide type 23F 1mcg
Pneumococcal polysaccharide type 4 3mcg
Pneumococcal polysaccharide type 5 1mcg
Pneumococcal polysaccharide type 6B 1mcg
Pneumococcal polysaccharide type 7F 1mcg
Pneumococcal polysaccharide type 9V 1mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
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Product:
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New Zealand Sponsor:
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Voltfast
Diclofenac potassium 50mg
Powder for oral solution
Novartis New Zealand Limited
Mipharm SpA, Milano, Italy
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Dated this 14th day of September 2018.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz