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:

Gemcitabine Dr. Reddy’s
Gemcitabine hydrochloride 227.71mg equivalent to Gemcitabine 200mg
Powder for infusion
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

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

Gemcitabine Dr Reddy’s
Gemcitabine hydrochloride 1138.52mg equivalent to Gemcitabine 1000mg
Powder for infusion
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

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

Gemcitabine Dr Reddy’s
Gemcitabine hydrochloride 2277mg equivalent to Gemcitabine 2000mg
Powder for infusion
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

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

Imbruvica
Ibrutinib 140mg
Capsule
Janssen-Cilag (New Zealand) Limited
Catalent CTS Inc, Missouri, United States of America

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Lemsip Max Cold & Flu with Decongestant Hot Drink
Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg equivalent to Phenylephrine 10mg
Powder for oral solution
Reckitt Benckiser (New Zealand) Limited
Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom

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

Lioresal Intrathecal
Baclofen 0.05mg/mL
Solution for injection
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

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

Lioresal Intrathecal
Baclofen 2mg/mL
Solution for injection
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

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

Renvela
Sevelamer carbonate 800mg
Film coated tablet
sanofi-aventis new zealand limited
Genzyme Ireland Limited, Waterford, Ireland

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

Renvela
Sevelamer carbonate 1600mg
Powder for oral suspension
sanofi-aventis new zealand limited
Genzyme Ireland Limited, Waterford, Ireland
Genzyme Limited, Suffolk, United Kingdom

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

Renvela
Sevelamer carbonate 2400mg
Powder for oral suspension
sanofi-aventis new zealand limited
Genzyme Ireland Limited, Waterford, Ireland
Genzyme Limited, Suffolk, United Kingdom

Dated this 23rd day of July 2015.

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