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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Apo-Azacitidine
Azacitidine 100mg
Powder for injection
Apotex NZ Limited
Gland Pharma Limited, Visakhapatnam, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Imatinib Mylan
Imatinib mesilate 119.5mg equivalent to imatinib base 100mg
Film coated tablet
Mylan New Zealand Limited
Remedica Limited, Limassol, Cyprus
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Imatinib Mylan
Imatinib mesilate 478mg equivalent to imatinib base 400mg
Film coated tablet
Mylan New Zealand Limited
Remedica Limited, Limassol, Cyprus
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Paracetamol Suppositories
Paracetamol 125mg
Suppository
PSM Healthcare Limited trading as API Consumer Brands
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Paracetamol Suppositories
Paracetamol 250mg
Suppository
PSM Healthcare Limited trading as API Consumer Brands
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Sumatriptan
Sumatriptan succinate 140mg equivalent to sumatriptan 100mg
Film coated tablet
REX Medical Limited
Cipla Limited, Verna, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Sumatriptan
Sumatriptan succinate 70mg equivalent to sumatriptan 50mg
Film coated tablet
REX Medical Limited
Cipla Limited, Verna, India
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Dated this 8th day of March 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz