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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Actemra
Tocilizumab 162mg/0.9mL
Solution for injection
Roche Products (NZ) Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Actemra
Tocilizumab 20mg/mL
Concentrate for infusion
Roche Products (NZ) Limited
Chugai Pharma Manufacturing Co. Limited, Utsunomiya, Japan
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Keytruda
Pembrolizumab 50mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
MSD International GmbH trading as MSD Ireland (Brinny), Innishannon, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Varivax
Varicella vaccine 1350PFU
Suspension for injection with diluent
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme Corp, Pennsylvania, United States of America
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Dated this 26th day of May 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