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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 Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Alendronic acid/colecalciferol
Alendronate sodium monohydrate 81.2mg equivalent to alendronic acid 70mg
Colecalciferol 0.07mg
Film coated tablet
Teva Pharma (New Zealand) Limited
Teva Pharmaceutical Industries Limited, Kfar Saba, Israel

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Alendronic acid/colecalciferol
Alendronate sodium monohydrate 81.2mg equivalent to alendronic acid 70mg
Colecalciferol 0.14mg
Film coated tablet
Teva Pharma (New Zealand) Limited
Teva Pharmaceutical Industries Limited, Kfar Saba, Israel

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Augmentin
Amoxicillin trihydrate 573.96mg equivalent to amoxicillin 500mg
Potassium clavulanate 148.91mg equivalent to clavulanic acid 125mg
Film coated tablet
GlaxoSmithKline (NZ) Limited
SmithKline Beecham Pharmaceuticals Limited, Worthing, United Kingdom
Glaxo Wellcome Production, Mayenne, France

Product:
Active Ingredients:




Dosage Form:
New Zealand Sponsor:
Manufacturer:

Bexsero
Neisseria meningitidis group B factor H binding protein fusion protein 50mcg
Neisseria meningitidis group B neisseria adhesin A protein 50mcg
Neisseria meningitidis group B neisseria heparin binding antigen fusion
protein 50mcg
Neisseria meningitidis sergroup B outer membrane vesicles 25mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Vaccines SRL, Sovicille, Italy

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

Cinacalcet Te Arai
Cinacalcet hydrochloride 33.075mg equivalent to cinacalcet 30mg
Film coated tablet
Te Arai BioFarma Limited
Bluepharma, Coimbra, Portugal

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

Cinacalcet Te Arai
Cinacalcet hydrochloride 66.15mg equivalent to cinacalcet 60mg
Film coated tablet
Te Arai BioFarma Limited
Bluepharma, Coimbra, Portugal

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

Cinacalcet Te Arai
Cinacalcet hydrochloride 99.225mg equivalent to cinacalcet 90mg
Film coated tablet
Te Arai BioFarma Limited
Bluepharma, Coimbra, Portugal

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

Goserelin
Goserelin acetate 4.1mg equivalent to goserelin 3.6mg
Subcutaneous implant
Teva Pharma (New Zealand) Limited
AMW GmbH Arzneimittelwerk Warngau, Warngau, Germany

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

Goserelin
Goserelin acetate 12.5mg equivalent to goserelin 10.8mg
Subcutaneous implant
Teva Pharma (New Zealand) Limited
AMW GmbH Arzneimittelwerk Warngau, Warngau, Germany

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

Microshield PVP Povidone-Iodine Surgical Handwash
Povidone-iodine 7.5%w/v equivalent to iodine 0.75% w/v
Topical solution
Schulke New Zealand Limited
Ensign Laboratories Pty Limited, Melbourne, Australia


Dated this 16th day of July 2018.

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