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:

Cubicin
Daptomycin 350mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
OSO BioPharmaceuticals Manufacturing, New Mexico, United States of America
Patheon Italia SpA, Milan, Italy

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

Cubicin
Daptomycin 500mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
Hospira Inc, McPherson, Kansas, United States of America
OSO BioPharmaceuticals Manufacturing, New Mexico, United States of America
Patheon Italia SpA, Milan, Italy

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

Dysport
Clostridium botulinum type A toxin haemagglutinin complex 300U
Powder for injection
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Ipsen Biopharm Limited, Wrexham, United Kingdom

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

Dysport
Clostridium botulinum type A toxin haemagglutinin complex 500U
Powder for injection
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Ipsen Biopharm Limited, Wrexham, United Kingdom

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

Lucentis
Ranibizumab 10mg/mL
Solution for injection
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
Sterigenics Belgium SA, Verviers, Belgium

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

Voltaren
Diclofenac sodium 25mg
Enteric coated tablet
Novartis New Zealand Limited
Novartis Farma SpA, Torre Annunziata, Italy
Novartis Saglik ve Gida Urunlei Sanayi ve Ticaret AS, Istanbul, Turkey

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

Voltaren
Diclofenac sodium 50mg
Enteric coated tablet
Novartis New Zealand Limited
Novartis Farma SpA, Torre Annunziata, Italy
Novartis Saglik ve Gida Urunlei Sanayi ve Ticaret AS, Istanbul, Turkey

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

Voltaren Ophtha
Diclofenac sodium 1mg/mL
Eye drops, solution
Novartis New Zealand Limited
Excelvision, Rue de la Lombardiere, Annonay Cedex, France

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

Voltaren SR
Diclofenac sodium 75mg
Modified release tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farma SpA, Torre Annunziata, Italy

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

Voltaren SR
Diclofenac sodium 100mg
Modified release tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

Dated this 9th 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).