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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Cyramza
Ramucirumab 100mg/10mL
Concentrate for infusion
Eli Lilly and Company (NZ) Limited
Eli Lilly and Co Inc, Indiana, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Cyramza
Ramucirumab 500mg/50mL
Concentrate for infusion
Eli Lilly and Company (NZ) Limited
Eli Lilly and Co Inc, Indiana, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Eplerenone Te Arai
Eplerenone 25mg
Film coated tablet
Te Arai Biofarma Limited
Laboratorios Liconsa SA, Guadalajara, Spain
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Eplerenone Te Arai
Eplerenone 50mg
Film coated tablet
Te Arai Biofarma Limited
Laboratorios Liconsa SA, Guadalajara, Spain
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Ibavyr
Ribavirin 200mg
Film coated tablet
Clinect NZ Pty Limited c/o Ebos Group Limited
Pharmascience Inc, Montreal, Canada
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Nurofen for Children Soft Chews
Ibuprofen 100mg
Soft gelatin capsule
Reckitt Benckiser (New Zealand) Limited
Patheon Softgels B.V., Tilburg, Netherlands
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Sirturo
Bedaquiline fumarate 120.89mg equivalent to bedaquiline 100mg
Tablet
Janssen-Cilag (New Zealand) Limited
Kemwell Biopharma Private Limited, Nelamangala, India
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Dated this 12th day of August 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz