✨ Consent to the Distribution of New Medicines




NEW ZEALAND GAZETTE, No. 112 β€” 1 DECEMBER 2016

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Noradrenaline BNM
Noradrenaline acid tartrate 2mg/mL equivalent to 1mg/mL noradrenaline base
Concentrate for injection
Boucher & Muir (New Zealand) Limited trading as BNM Group
Sintetica SA, Mendrisio, Switzerland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Robitussin Dry Cough Liquid Capsules
Dextromethorphan hydrobromide monohydrate 15mg
Liquid filled capsule
Pfizer New Zealand Limited
Catalent Pharma Solutions LLC, Florida, United States of America

Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Zepatier
Elbasvir 50mg
Grazoprevir 100mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
MSD International GmbH (Ireland), Clonmel, Ireland

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).

2016-go6758

Consent to the Distribution of New Medicines

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

Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

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

Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

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

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

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

Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

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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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 112





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
28 November 2016
Medicines, Distribution, Consent, New Medicines, Noradrenaline, Robitussin, Zepatier
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
28 November 2016
Medicines, Distribution, Consent, New Medicines, Fluarix, Fluarix Tetra, Octostim, Priorix-Tetra
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health