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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Fexaclear
Fexofenadine hydrochloride 120mg
Film coated tablet
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Bachupally, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Proveblue
Methylthioninium chloride hydrate 5mg/mL
equivalent to methylthioninium chloride trihydrate 5mg/mL
Solution for injection
Clinect NZ Pty Limited c/o Ebos Group Limited
Cenexi SAS, Paris, France
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Robitussin Chesty Cough
Guaifenesin 200mg
Liquid filled capsule
Pfizer New Zealand Limited
Catalent Australia Pty Limited, Melbourne, Australia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Synagis
Palivizumab 50mg/0.5mL
Solution for injection
AbbVie Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
MedImmune Pharma BV, Nijmegen, Netherlands
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Synagis
Palivizumab 100mg/1mL
Solution for injection
AbbVie Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
MedImmune Pharma BV, Nijmegen, Netherlands
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Dated this 21st day of July 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