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:

3TC
Lamivudine 150mg
Film coated tablet
GlaxoSmithKline (NZ) Limited
Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Ware, United Kingdom
GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland

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

3TC
Lamivudine 300mg
Film coated tablet
GlaxoSmithKline (NZ) Limited
Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Ware, United Kingdom
GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland

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

3TC
Lamivudine 10mg/mL
Oral solution
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline (Canada) Inc, Mississauga, Canada

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

Fosamax
Alendronate sodium trihydrate 6.53mg equivalent to alendronic acid 5mg
Tablet
Merck Sharp & Dohme (New Zealand) Limited
Savio Industrial Srl, Pavia, Italy

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

Fosamax
Alendronate sodium trihydrate 52.21mg equivalent to alendronic acid 40mg
Tablet
Merck Sharp & Dohme (New Zealand) Limited
Savio Industrial Srl, Pavia, Italy
Aesica Pharmaceuticals GmbH, Zwickau, Germany

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

Fosamax
Alendronate sodium trihydrate 91.37mg equivalent to alendronic acid 70mg
Tablet
Merck Sharp & Dohme (New Zealand) Limited
Savio Industrial Srl, Pavia, Italy
Aesica Pharmaceuticals GmbH, Zwickau, Germany

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

Neutrafluor 5000 Plus
Sodium fluoride 1.105%w/w equivalent to 5000 ppm fluoride ion
Toothpaste
Colgate-Palmolive Limited (NZ)
Colgate-Palmolive Company, Tennessee, United States of America

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

Nurofen Quickzorb (General sale)
Ibuprofen lysine 342mg equivalent to ibuprofen 200mg
Film coated tablet
Reckitt Benckiser (New Zealand) Limited
Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom

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

Nurofen Quickzorb (Pharmacy only)
Ibuprofen lysine 342mg equivalent to ibuprofen 200mg
Film coated tablet
Reckitt Benckiser (New Zealand) Limited
Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom

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

Praluent
Alirocumab 75mg/mL
Solution for injection
Sanofi-Aventis New Zealand Limited
Sanofi Winthrop Industrie, Le Trait, France
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
Sanofi Pasteur Inc, Pennsylvania, United States of America

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

Praluent
Alirocumab 150mg/mL
Solution for injection
Sanofi-Aventis New Zealand Limited
Sanofi Winthrop Industrie, Le Trait, France
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany

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

Ropivacaine Kabi
Ropivacaine hydrochloride 2mg/mL equivalent to ropivacaine 1.77mg/mL
Solution for injection
Fresenius Kabi New Zealand Limited
Fresenius Kabi Norge AS, Halden, Norway

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

Ropivacaine Kabi
Ropivacaine hydrochloride 5mg/mL equivalent to ropivacaine 4.43mg/mL
Solution for injection
Fresenius Kabi New Zealand Limited
Fresenius Kabi Norge AS, Halden, Norway

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

Ropivacaine Kabi
Ropivacaine hydrochloride 7.5mg/mL equivalent to ropivacaine 6.64mg/mL
Solution for injection
Fresenius Kabi New Zealand Limited
Fresenius Kabi Norge AS, Halden, Norway

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

Ropivacaine Kabi
Ropivacaine hydrochloride 10mg/mL equivalent to ropivacaine 8.85mg/mL
Solution for injection
Fresenius Kabi New Zealand Limited
Fresenius Kabi Norge AS, Halden, Norway

Product:
Component 1:
Active Ingredient:
Dosage Form:
Manufacturer:
Component 2:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

ZolaCos CP (Combination Product)

Goserelin acetate 3.8mg equivalent to goserelin 3.6mg
Subcutaneous implant
AstraZeneca UK Limited, Macclesfield, United Kingdom

Bicalutamide 50mg
Film coated tablet
AstraZeneca Limited
Corden Pharma GmbH, Plankstadt, Germany

Product:
Component 1:
Active Ingredient:
Dosage Form:
Manufacturer:
Component 2:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

ZolaCos CP (Combination Product)

Goserelin acetate 11.34mg equivalent to goserelin 10.8mg
Subcutaneous implant
AstraZeneca UK Limited, Macclesfield, United Kingdom

Bicalutamide 50mg
Film coated tablet
AstraZeneca Limited
Corden Pharma GmbH, Plankstadt, Germany

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

Zoladex 3.6mg
Goserelin acetate 3.8mg equivalent to goserelin 3.6mg
Subcutaneous implant
AstraZeneca Limited
AstraZeneca UK Limited, Macclesfield, United Kingdom

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

Zoladex 10.8mg
Goserelin acetate 11.34mg equivalent to goserelin 10.8mg
Subcutaneous implant
AstraZeneca Limited
AstraZeneca UK Limited, Macclesfield, United Kingdom

Dated this 13th day of May 2019.

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