Consent to the Distribution of New Medicines
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:
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Product: |
Arsenic trioxide – AFT (10mg/10mL) |
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Active Ingredient: |
Arsenic trioxide 1mg/mL |
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Dosage Form: |
Concentrate for infusion |
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New Zealand Sponsor: |
AFT Pharmaceuticals Limited |
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Manufacturer: |
Kocak Farma Ilac Ve Kimya Sanayi A.S., Tekirdag, Turkey |
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Product: |
Arsenic trioxide – AFT (12mg/12mL) |
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Active Ingredient: |
Arsenic trioxide 1mg/mL |
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Dosage Form: |
Concentrate for infusion |
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New Zealand Sponsor: |
AFT Pharmaceuticals Limited |
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Manufacturer: |
Kocak Farma Ilac Ve Kimya Sanayi A.S., Tekirdag, Turkey |
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Product: |
Azacitidine SXP |
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Active Ingredient: |
Azacitidine 100mg |
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Dosage Form: |
Powder for injection |
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New Zealand Sponsor: |
Southern XP Pty Limited |
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Manufacturer: |
Sichuan Huiyu Pharmaceutical Company Limited, Neijiang, China |
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Product: |
Pharmacor Fingolimod |
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Active Ingredient: |
Fingolimod hydrochloride 0.56mg equivalent to fingolimod 0.5mg |
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Dosage Form: |
Capsule |
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New Zealand Sponsor: |
Pharmacor Limited |
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Manufacturer: |
Alkem Laboratories Limited, Nalagarh, India |
Dated this 21st day of March 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).