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:

Fungilin
Amphotericin B 10mg
Lozenge
Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Aspen Pharma Pty Limited, Melbourne, Australia

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

Humira
Adalimumab 10mg/0.2mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

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

Humira
Adalimumab 20mg/0.4mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg,

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

Humira
Adalimumab 50mg/mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Humira Pen
Adalimumab 50mg/mL
Solution for injection
AbbVie Limited
Aesica Queenborough Limited, Queenborough, United Kingdom
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Product:
Active Ingredients:












Dosage Form:

New Zealand Sponsor:
Manufacturers:

Prevenar 13
Pneumococcal polysaccharide serotype 6A 2.2mcg
Pneumococcal polysaccharide type 1 2.2mcg
Pneumococcal polysaccharide type 14 2.2mcg
Pneumococcal polysaccharide type 18C 2.2mcg
Pneumococcal polysaccharide type 19A 2.2mcg
Pneumococcal polysaccharide type 19F 2.2mcg
Pneumococcal polysaccharide type 23F 2.2mcg
Pneumococcal polysaccharide type 3 2.2mcg
Pneumococcal polysaccharide type 4 2.2mcg
Pneumococcal polysaccharide type 5 2.2mcg
Pneumococcal polysaccharide type 6B 4.4mcg
Pneumococcal polysaccharide type 7F 2.2mcg
Pneumococcal polysaccharide type 9V 2.2mcg
Suspension for injection
Pfizer New Zealand Limited
Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, New York, United States of America
Baxter BioPharma Solutions LLC, Bloomington, United States of America
Pfizer Ireland Pharmaceuticals, Dublin, Ireland

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

Winglore
Ipilimumab 50mg/10mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limted, Manati, Puerto Rico

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

Winglore
Ipilimumab 200mg/40mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico

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

Yervoy
Ipilimumab 50mg/10mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico

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

Yervoy
Ipilimumab 200mg/40mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico

Dated this 27th day of October 2016.

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