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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Fluarix
Influenza virus A/California/7/2009 (H1N1) – like strain 30mcg/mL
Influenza virus A/Hong Kong/4801/2014 (H3N2) – like strain 30mcg/mL
Influenza virus B/Brisbane/60/2008 – like strain 30mcg/mL
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals (Dresden), Dresden, Germany
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Fluarix Tetra
Influenza virus A/California/7/2009 (H1N1) – like strain 15mcg
Influenza virus A/Texas/50/2012 (H3N2) – like strain 15mcg
Influenza virus B/Massachusetts/2/2012 – like strain 15mcg
Influenza virus B/Yamagata 16/88 15mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals (Dresden), Dresden, Germany
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Octostim
Desmopressin acetate trihydrate 1.5mg/mL
equivalent to 1.34mg/mL desmopressin free base
Nasal spray solution
Pharmaco (NZ) Limited
Rechon Life Science AB, Kiel, Germany
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Priorix-Tetra
Measles vaccine, Schwarz strain 1000CCID50
Mumps virus, live attenuated, RIT 4385 25119CCID50
Rubella virus, Wistar RA27/3 strain 1000CCID50
Varicella vaccine 1995PFU
Powder for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
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Saizen
Somatropin 5.83mg/mL
Solution for injection
Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Merck Serono SpA, Bari, Italy
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Saizen
Somatropin 8mg/mL
Solution for injection
Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Merck Serono SpA, Bari, Italy
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Saizen 3
Somatropin 3.33mg equivalent to 10 IU
Powder for injection
Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Merck Serono SA, Aubonne, Switzerland
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Saizen 8
Somatropin 8.8mg
Powder for injection
Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Merck Serono SA, Aubonne, Switzerland
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Dated this 28th day of November 2016.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz