Notice Type
Departmental
Notice Title

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: Naprosyn SR
Active Ingredient: Naproxen 750mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Clinect NZ Pty Limited
Manufacturer: Recipharm Leganes S.L.U., Leganes, Spain
   
Product: Naprosyn SR
Active Ingredient: Naproxen 1000mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Clinect NZ Pty Limited
Manufacturer: Recipharm Leganes S.L.U., Leganes, Spain
   
Product: Priorix-Tetra
Active Ingredients: Measles vaccine, Schwarz strain 1000CCID50
Mumps virus, live attenuated, RIT 4385 25119CCID50
Rubella virus, Wistar RA27/3 strain 1000CCID50
Varicella vaccine 1995PFU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Wavre, Belgium
   
Product: Varilrix Vaccine
Active Ingredient: Varicella vaccine 2000PFU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: Fidia Farmaceutici SpA, Abano Terme, Italy
Corixa Corporation dba GlaxoSmithKline Vaccines, Pennsylvania, United States of America


Dated this 20th day of February 2023.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).