Medicine Distribution Consents




NEW ZEALAND GAZETTE, No. 126

12 SEPTEMBER 2013

Pneumococcal Polysaccharide type 23F 2.2mcg
Pneumococcal Polysaccharide type 3 2.2mcg
Pneumococcal Polysaccharide type 4 2.2mcg
Pneumococcal Polysaccharide type 5 2.2mcg
Pneumococcal Polysaccharide type 6B 4.4mcg
Pneumococcal Polysaccharide type 7F 2.2mcg
Pneumococcal Polysaccharide type 9V 2.2mcg

Dosage Form:
Suspension for injection

New Zealand Sponsor:
Pfizer New Zealand Limited

Manufacturers:
Pfizer Ireland Pharmaceuticals, Dublin, Ireland
Wyeth Pharmaceuticals Inc, New York, United States of America
Baxter BioPharma Solutions LLC, Indiana, United States of America

Product:
Zevalin

Active Ingredient:
Ibritumomab tiuxetan 1.6mg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Bayer New Zealand Limited

Manufacturer:
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America

Dated this 5th day of September 2013.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).

go5791

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:
Axiron

Active Ingredient:
Testosterone 2%w/v

Dosage Form:
Topical solution

New Zealand Sponsor:
Eli Lilly and Company (NZ) Limited

Manufacturer:
Orion Corporation, Turku, Finland

Product:
Hydralyte™ Apple Blackcurrant Effervescent Electrolyte Tablets

Active Ingredients:
Citric acid 672mg
Glucose 1620mg
Potassium chloride 149mg
Sodium bicarbonate 378mg
Sodium chloride 87.5mg

Dosage Form:
Effervescent tablet

New Zealand Sponsor:
Hydration Pharmaceuticals Pty Limited

Manufacturer:
Alpex Pharma SA, Mezzovico, Switzerland

Product:
Hydralyte™ Orange Effervescent Electrolyte Tablets

Active Ingredients:
Citric acid 672mg
Glucose 1620mg
Potassium chloride 149mg
Sodium bicarbonate 378mg
Sodium chloride 87.5mg

Dosage Form:
Effervescent tablet

New Zealand Sponsor:
Hydration Pharmaceuticals Pty Limited

Manufacturer:
Alpex Pharma SA, Mezzovico, Switzerland

Product:
Imatinib-AFT

Active Ingredient:
Imatinib mesilate 477.88mg equivalent to Imatinib 400mg

Dosage Form:
Capsule

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Pabianickie Zakłady Farmaceutyczne Polfa SA, Pabianice, Poland

Product:
Imatinib-AFT

Active Ingredient:
Imatinib mesilate 119.47mg equivalent to Imatinib 100mg

Dosage Form:
Capsule

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Pabianickie Zakłady Farmaceutyczne Polfa SA, Pabianice, Poland



Next Page →



Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 126





✨ LLM interpretation of page content

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

🏥 Health & Social Welfare
5 September 2013
Medicines Act, Distribution consent, New medicines, Prevenar 13, Zevalin, Axiron, Hydralyte, Imatinib-AFT
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
5 September 2013
Medicines Act, Distribution consent, New medicines, Axiron, Hydralyte, Imatinib-AFT
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health