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
Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Chloramphenicol LINK Chloramphenicol sodium succinate 1.4g equivalent to chloramphenicol 1g Powder for injection Link Pharmaceuticals Limited VUAB Pharma A.S, Roztoky, Czech Republic
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Sirdupla MDI Fluticasone propionate 0.125mg equivalent to 125mcg/dose Salmeterol xinafoate 0.0363mg equivalent to salmeterol 25mcg/dose Aerosol inhaler, metered dose Mylan New Zealand Limited 3M Health Care (UK) Limited, Loughborough, United Kingdom
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Sirdupla MDI Fluticasone propionate 0.25mg equivalent to 250mcg/dose Salmeterol xinafoate 0.0363mg equivalent to salmeterol 25mcg/dose Aerosol inhaler, metered dose Mylan New Zealand Limited 3M Health Care (UK) Limited, Loughborough, United Kingdom
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Tenofovir Disoproxil Emtricitabine Efavirenz Mylan Efavirenz 600mg Emtricitabine 200mg Tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg Film coated tablet Mylan New Zealand Limited Mylan Laboratories Limited, Pithampur, India
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Dated this 19th day of July 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).