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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Adenosine-Claris
Adenosine 30mg/10mL
Solution for injection
AFT Pharmaceuticals Limited
Claris Injectables Limited, Ahmedabad, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Adenosine-Claris
Adenosine 6mg/2mL
Solution for injection
AFT Pharmaceuticals Limited
Claris Injectables Limited, Ahmedabad, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Children’s Claratyne
Loratadine 5mg
Chewable tablet
Bayer New Zealand Limited
Pantheon Manufacturing Services LLC, North Carolina, United States of America
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Entop Plus
Lidocaine hydrochloride 50mg/mL
Phenylephrine hydrochloride 5mg/mL
Nasal spray solution
Flo Pharmaceuticals Limited
Mayne Pharma International Pty Limited, Adelaide, Australia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Ketamine Mylan
Ketamine hydrochloride 115.3mg/mL equivalent to ketamine 100mg/mL
Solution for injection
Mylan New Zealand Limited
Mylan Teoranta Limited, Galway, Ireland
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Dated this 25th day of August 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz