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:

Champix
Varenicline tartrate 0.85mg equivalent to varenicline 0.5mg
Film coated tablet
Pfizer New Zealand Limited
R-Pharm Germany GmbH, Illertissen, Germany

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

Champix
Varenicline tartrate 1.71mg equivalent to varenicline 1mg
Film coated tablet
Pfizer New Zealand Limited
R-Pharm Germany GmbH, Illertissen, Germany

Product:
Active Ingredient:
Dosage Form:
Active Ingredient:
Dosage Form:

New Zealand Sponsor:
Manufacturers:

Champix 0.5mg and 1mg tablets (Combination Product)
Varenicline tartrate 0.85mg equivalent to varenicline 0.5mg
Film coated tablet
Varenicline tartrate 1.71mg equivalent to varenicline 1mg
Film coated tablet
Pfizer New Zealand Limited
R-Pharm Germany GmbH, Illertissen, Germany

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Creon 10,000
Pancreatin 150mg equivalent to amylase 8,000 Ph Eur U,
lipase 10,000 Ph Eur U, total protease 600 Ph Eur U
Modified release capsule
BGP Products
Abbott Laboratories GmbH, Neustadt, Germany

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Creon 25,000
Pancreatin 300mg equivalent to amylase 18,000 Ph Eur U,
lipase 25,000 Ph Eur U, total protease 1,000 Ph Eur U
Modified release capsule
BGP Products
Abbott Laboratories GmbH, Neustadt, Germany

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturers:

Truvada
Emtricitabine 200mg
Tenofovir disoproxil fumarate 300mg equivalent to tenofovir disoproxil 245mg
Tablet
Gilead Sciences (NZ)
Patheon Inc, Mississauga, Canada
Patheon Inc, Whitby, Canada
Takeda GmbH, Oranienburg, Germany
Gilead Sciences Ireland UC, County Cork, Ireland
Rottendorf Pharma GmbH, Ennigerloh, Germany

Dated this 20th day of January 2017.

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