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:

APO-Capecitabine
Capecitabine 150mg
Film coated tablet
Apotex NZ Limited
Apotex Inc, Ontario, Canada

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

APO-Capecitabine
Capecitabine 500mg
Film coated tablet
Apotex NZ Limited
Apotex Inc, Ontario, Canada

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

Astepro
Azelastine hydrochloride 1.5mg/mL
Nasal spray solution
CARSL Consulting
MEDA Pharmaceuticals Inc, Illinois, United States of America

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

DBL™ Tranexamic Acid Injection
Tranexamic acid 100mg/mL
Solution for injection
Hospira NZ Limited
Medochemie Limited, Limassol, Cyprus

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

Hospira™ Tranexamic Acid Injection
Tranexamic acid 100mg/mL
Solution for injection
Hospira NZ Limited
Medochemie Limited, Limassol, Cyprus

Product:
Component 1:

Active Ingredients:



Dosage Form:
Component 2:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:

Manufacturer:

Moviprep Orange

Macrogol 3350 100g
Potassium chloride 1.015g
Sodium chloride 2.691g
Sodium sulfate 7.5g
Powder for oral solution

Ascorbic acid 4.7g
Sodium ascorbate 5.9g
Powder for oral solution
CARSL Consulting
Norgine (UK) Limited, Mid-Glamorgan, United Kingdom

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

Naglazyme
Galsulfase 1mg/mL
Concentrate for infusion
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Jubilant Hollister-Stier LLC, Washington, United States of America
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Dated this 18th day of March 2016.

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