✨ 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).
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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
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✨ LLM interpretation of page content
🏥
Consent to the Distribution of New Medicines
(continued from previous page)
🏥 Health & Social Welfare5 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 Welfare5 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
NZ Gazette 2013, No 126