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

Bydureon
Exenatide 2mg
Powder for injection
AstraZeneca Limited
Amylin Ohio Inc, Ohio, United States of America

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Ethics Soothing Medicated Throat Lozenges
Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Lozenge
Multichem NZ Limited
Cipla Limited, Nalagarh, India
Makson Health Care (Private) Limited, Manideep, India

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

Forxiga
Dapagliflozin propanediol monohydrate 12.3mg equivalent to dapaglifozin 10mg
Film coated tablet
AstraZeneca Limited
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
AstraZeneca Pharmaceuticals LP, Indiana, United States of America

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

Mekinist
Trametinib dimethyl sulfoxide 0.5635mg equivalent to trametinib 0.5mg
Film coated tablet
Novartis New Zealand Limited
GlaxoSmithKline Manufacturing SpA, Parma, Italy

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

Mekinist
Trametinib dimethyl sulfoxide 2.254mg equivalent to trametinib 2mg
Film coated tablet
Novartis New Zealand Limited
GlaxoSmithKline Manufacturing SpA, Parma, Italy

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturers:

Priorix
Measles vaccine, Schwarz strain 1000CCID50
Mumps virus, live attenuated, RIT 4385 5012CCID50
Rubella virus, Wistar RA27/3 strain 1000CCID50
Powder for injection with diluent
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Fidia Farmaceutici SpA, Abano Terme, Italy
Corixia Corporation dba GlaxoSmithKline Vaccines, Pennsylvania, United States of America

Product:
Active Ingredients:



Dosage Form:
New Zealand Sponsor:
Manufacturers:

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 with diluent
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Wavre, Belgium

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

Tafinlar
Dabrafenib mesilate 59.25mg equivalent to dabrafenib 50mg
Capsule
Novartis New Zealand Limited
GlaxoSmithKline (Canada) Inc, Mississauga, Canada
Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Ware, United Kingdom

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

Tafinlar
Dabrafenib mesilate 88.88mg equivalent to dabrafenib 75mg
Capsule
Novartis New Zealand Limited
GlaxoSmithKline (Canada) Inc, Mississauga, Canada
Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Ware, United Kingdom

Product:
Active Ingredients:





Dosage Form:
New Zealand Sponsor:
Manufacturer:

Tripacel
Diphtheria toxoid, adsorbed 30IU
Pertactin 3mcg
Pertussis filamentous haemagglutinin 5mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 10mcg
Tetanus toxoid, adsorbed 40IU
Suspension for injection
Sanofi-Aventis New Zealand Limited
Sanofi Pasteur Limited, Toronto, Canada

Dated this 29th day of May 2019.

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