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:
Manufacturers:

Alanase
Beclometasone dipropionate 0.5mg/g
Nasal spray solution
Mylan New Zealand Limited
Mylan Specialty L.P., California, United States of America
Patheon France SA, Bourgoin Jallieu, France

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

Alanase 100
Beclometasone dipropionate 1mg/g
Nasal spray solution
Mylan New Zealand Limited
Mylan Specialty L.P., California, United States of America
Patheon France SA, Bourgoin Jallieu, France

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, Germany

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
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Aesica Queenborough Limited, Queenborough, United Kingdom
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Norspan
Buprenorphine 5mg
Transdermal patch
Mundipharma New Zealand Ltd
LTS Lohmann Therapie-Systeme AG, Andernach, Germany

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

Norspan
Buprenorphine 10mg
Transdermal patch
Mundipharma New Zealand Ltd
LTS Lohmann Therapie-Systeme AG, Andernach, Germany

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

Norspan
Buprenorphine 20mg
Transdermal patch
Mundipharma New Zealand Limited
LTS Lohmann Therapie-Systeme AG, Andernach, Germany

Product:
Active Ingredients:



Dosage Form:

New Zealand Sponsor:
Manufacturers:

Stribild
Cobicistat 150mg
Elvitegravir 150mg
Emtricitabine 200mg
Tenofovir disoproxil fumarate 300mg
Film coated tablet
Gilead Sciences (NZ)
Patheon Inc, Mississauga, Canada
Gilead Sciences Ireland UC, Carrigtohill, Ireland

Dated this 18th day of February 2016.

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