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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Antizol
Fomepizole 1g/mL
Solution for injection
AFT Pharmaceuticals Limited
Afton Scientific LLC, Virginia, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Dexmedetomidine-Teva
Dexmedetomidine hydrochloride 118mcg/mL
equivalent to dexmedetomidine 100mcg/mL
Concentrate for infusion
Teva Pharma (New Zealand) Limited
PLIVA Croatia Limited, Zagreb, Croatia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Dimetapp 12 Hour Nasal Spray (General sale)
Oxymetazoline hydrochloride 0.5mg/mL
Nasal spray solution
Pfizer New Zealand Limited
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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Valganciclovir
Valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450mg
Film coated tablet
REX Medical Limited
Cipla Limited, Patalanga Raigad, India
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Dated this 18th day of December 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