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 Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Aciclovir-Claris
Aciclovir 25mg/mL
Solution for infusion
AFT Pharmaceuticals Limited
Claris Life Sciences Limited, Gujarat, India

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

Cefuroxime Actavis
Cefuroxime sodium 789mg equivalent to Cefuroxime 750mg
Powder for injection
Actavis New Zealand Limited
Facta Farmaceutica SpA, Teramo, Italy

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

Cefuroxime Actavis
Cefuroxime sodium 1578mg equivalent to Cefuroxime 1500mg
Powder for injection
Actavis New Zealand Limited
Facta Farmaceutica SpA, Teramo, Italy

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

Clonidine Transdermal System, USP
Clonidine 2.52mg equivalent to 0.1mg/24hr
Transdermal patch
Mylan New Zealand Limited
Mylan Technologies, Vermont, United States of America

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

Clonidine Transdermal System, USP
Clonidine 5.04mg equivalent to 0.2mg/24hr
Transdermal patch
Mylan New Zealand Limited
Mylan Technologies, Vermont, United States of America

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

Clonidine Transdermal System, USP
Clonidine 7.56mg equivalent to 0.3mg/24hr
Transdermal patch
Mylan New Zealand Limited
Mylan Technologies, Vermont, United States of America

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

Gacet
Paracetamol 125mg
Suppository
AFT Pharmaceuticals Limited
Bliss GVS Pharma Limited, Maharashtra, India

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

Invokana
Canagliflozin hemihydrate 102mg equivalent to Canagliflozin 100mg
Film coated tablet
Janssen-Cilag (New Zealand) Limited
Janssen Ortho LLC, Gurabo, Puerto Rico

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

Invokana
Canagliflozin hemihydrate 306mg equivalent to Canagliflozin 300mg
Film coated tablet
Janssen-Cilag (New Zealand) Limited
Janssen Ortho LLC, Gurabo, Puerto Rico

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

Lice Clear
Permethrin 1%w/w
Scalp lotion
AFT Pharmaceuticals Limited
Hoe Pharmaceuticals Sdn Bhd, Selangor, Malaysia

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

Opsumit
Macitentan 10mg
Film coated tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Patheon Italia SpA, Milan, Italy

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

Travopt
Travoprost 0.04mg/mL
Eye drops, solution
Mylan New Zealand Limited
Wintac Limited, Karnataka, India

Dated this 13th day of November 2014.

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