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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Atgam
Antithymocyte immunoglobulin 50mg/mL
Concentrate for injection
Pfizer New Zealand Limited
Pharmacia & Upjohn Company, Michigan, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Forxiga
Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapaglifozin 10mg
Film coated tablet
AstraZeneca Limited
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Bristol-Myers Squibb Company, Indiana, United States of America
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Pediacel
Diphtheria toxoid, adsorbed 15Lf U
Haemophilus influenzae type b polysaccharide 10mcg
Pertactin 3mcg
Pertussis filamentous haemagglutinin 20mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 20mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid 20mcg
Tetanus toxoid, adsorbed 5Lf U
Suspension for injection
sanofi-aventis new zealand limited
Sanofi Pasteur Limited, Ontario, Canada
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Dated this 20th day of March 2015.
SARAH READER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz