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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Ceftazidime-AFT
Ceftazidime pentahydrate 1.16g equivalent to ceftazidime 1g
Powder for injection
AFT Pharmaceuticals Limited
Qilu Pharmaceutical Co Limited, Jinan, China
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Ceftazidime-AFT
Ceftazidime pentahydrate 2.33g equivalent to ceftazidime 2g
Powder for injection
AFT Pharmaceuticals Limited
Qilu Pharmaceutical Co Limited, Jinan, China
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Cefuroxime
Cefuroxime sodium 263mg equivalent to cefuroxime 250mg
Powder for injection
Devatis Limited
Deva Holding AS, Tekirdag, Turkey
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Cefuroxime
Cefuroxime sodium 789mg equivalent to cefuroxime 750mg
Powder for injection
Devatis Limited
Deva Holding AS, Tekirdag, Turkey
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Cefuroxime
Cefuroxime sodium 1578mg equivalent to cefuroxime 1500mg
Powder for injection
Devatis Limited
Deva Holding AS, Tekirdag, Turkey
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Erlidona 20
Ethinylestradiol 0.02mg
Levonorgestrel 0.1mg
Film coated tablet
Teva Pharma (New Zealand) Limited
Laboratorios Leon Farma S.A., Leon, Spain
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Erlidona 20
Ethinylestradiol 0.03mg
Levonorgestrel 0.15mg
Film coated tablet
Teva Pharma (New Zealand) Limited
Laboratorios Leon Farma S.A., Leon, Spain
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
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Solifenacin Sandoz
Solifenacin succinate 5mg
Film coated tablet
Novartis New Zealand Limited
Lek Pharmaceuticals d.d., Ljubljana, Slovenia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
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Solifenacin Sandoz
Solifenacin succinate 10mg
Film coated tablet
Novartis New Zealand Limited
Lek Pharmaceuticals d.d., Ljubljana, Slovenia
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Dated this 21st day of June 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz