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 set out in the Schedule hereto:

Schedule

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

Kovaltry
Octocog alfa 250IU
Powder for injection with diluent
Bayer New Zealand Limited
Bayer Healthcare LLC, California, United States of America

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

Kovaltry
Octocog alfa 500IU
Powder for injection with diluent
Bayer New Zealand Limited
Bayer Healthcare LLC, California, United States of America

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

Kovaltry
Octocog alfa 1000IU
Powder for injection with diluent
Bayer New Zealand Limited
Bayer Healthcare LLC, California, United States of America

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

Kovaltry
Octocog alfa 2000IU
Powder for injection with diluent
Bayer New Zealand Limited
Bayer Healthcare LLC, California, United States of America

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

Kovaltry
Octocog alfa 3000IU
Powder for injection with diluent
Bayer New Zealand Limited
Bayer Healthcare LLC, California, United States of America

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

Thiamine Hydrochloride Tablets
Thiamine hydrochloride 50mg
Tablet
Max Health Limited
Surepharm Services Limited, Burton upon Trent, United Kingdom

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

Venclexta
Venetoclax 10mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland

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

Venclexta
Venetoclax 50mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland

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

Venclexta
Venetoclax 100mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland

Product:
Component 1:

Active Ingredient:
Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
Component 3:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Venclexta

Venetoclax 10mg
Film coated tablet

Venetoclax 50mg
Film coated tablet

Venetoclax 100mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland

Dated this 27th day of October 2017.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).