Medicine Consent Notices




NEW ZEALAND GAZETTE, No. 83 — 30 JULY 2015

Product:
Active Ingredient:
Gemcitabine hydrochloride 1138.52mg equivalent to Gemcitabine 1000mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Dr Reddy’s New Zealand Limited
Manufacturer:
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Gemcitabine Dr Reddy’s


Product:
Active Ingredient:
Gemcitabine hydrochloride 2277mg equivalent to Gemcitabine 2000mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Dr Reddy’s New Zealand Limited
Manufacturer:
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Gemcitabine Dr Reddy’s


Product:
Active Ingredient:
Ibrutinib 140mg
Dosage Form:
Capsule
New Zealand Sponsor:
Janssen-Cilag (New Zealand) Limited
Manufacturer:
Catalent CTS Inc, Missouri, United States of America

Imbruvica


Product:
Active Ingredients:
Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg equivalent to Phenylephrine 10mg
Dosage Form:
Powder for oral solution
New Zealand Sponsor:
Reckitt Benckiser (New Zealand) Limited
Manufacturer:
Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom

Lemsip Max Cold & Flu with Decongestant Hot Drink


Product:
Active Ingredient:
Baclofen 0.05mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer:
Novartis Pharma Stein AG, Stein, Switzerland

Lioresal Intrathecal


Product:
Active Ingredient:
Baclofen 2mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer:
Novartis Pharma Stein AG, Stein, Switzerland

Lioresal Intrathecal


Product:
Active Ingredient:
Sevelamer carbonate 800mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
sanofi-aventis new zealand limited
Manufacturer:
Genzyme Ireland Limited, Waterford, Ireland

Renvela


Product:
Active Ingredient:
Sevelamer carbonate 1600mg
Dosage Form:
Powder for oral suspension
New Zealand Sponsor:
sanofi-aventis new zealand limited
Manufacturers:
Genzyme Ireland Limited, Waterford, Ireland
Genzyme Limited, Suffolk, United Kingdom

Renvela


Product:
Active Ingredient:
Sevelamer carbonate 2400mg
Dosage Form:
Powder for oral suspension
New Zealand Sponsor:
sanofi-aventis new zealand limited
Manufacturers:
Genzyme Ireland Limited, Waterford, Ireland
Genzyme Limited, Suffolk, United Kingdom

Renvela

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).

2015-go4407

Consent to the Distribution of New Medicines

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2015, No 83





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
23 July 2015
Medicines, Distribution, Gemcitabine, Dr. Reddy’s, Ibrutinib, Paracetamol, Phenylephrine, Baclofen, Sevelamer
  • Chris James, Acting Group Manager, Medsafe, Ministry of Health