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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Capecitabine
Capecitabine 150mg
Film coated tablet
REX Medical Limited
Cipla Limited, Goa, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Capecitabine
Capecitabine 500mg
Film coated tablet
REX Medical Limited
Cipla Limited, Goa, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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m-Azithromycin
Azithromycin dihydrate 262.05mg equivalent to Azithromycin 250mg
Film coated tablet
Multichem NZ Limited
Sunshine Lake Pharma Co. Limited, GuanDong Province, China
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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m-Azithromycin
Azithromycin dihydrate 524.1mg equivalent to Azithromycin 500mg
Film coated tablet
Multichem NZ Limited
Sunshine Lake Pharma Co. Limited, GuanDong Province, China
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Rabipur
Rabies vaccine 2.5IU
Injection with diluent
bioCSL (NZ) Limited
Novartis Vaccines & Diagnostics GmBH & Co KG, Marburg, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Xalkori
Crizotinib 200mg
Capsule, powder filled
Pfizer New Zealand Limited
Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Xalkori
Crizotinib 250mg
Capsule, powder filled
Pfizer New Zealand Limited
Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
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Dated this 20th day of February 2015.
SARAH READER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz