Medicines Distribution Consents




NEW ZEALAND GAZETTE, No. 153 — 18 DECEMBER 2014

Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product:
Eylea
Active Ingredient:
Aflibercept 40mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Bayer New Zealand Limited
Manufacturer:
Regeneron Pharmaceuticals Inc, New York, United States of America

Dated this 12th day of December 2014.

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

2014-go7769

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:
FluQuadri
Active Ingredients:
Influenza virus A/California/7/2009 (H1N1) – like strain 15mcg
Influenza virus A/Victoria/361/2011 (H3N2) – like strain 15mcg
Influenza virus B/Brisbane/60/2008 – like strain 15mcg
Influenza virus B/Massachusetts/2/2012 – like strain 15mcg
Dosage Form:
Suspension for injection
New Zealand Sponsor:
sanofi-aventis new zealand limited
Manufacturer:
Sanofi Pasteur Inc, Pennsylvania, United States of America

Product:
FluQuadri Junior
Active Ingredients:
Influenza virus A/California/7/2009 (H1N1) – like strain 7.5mcg
Influenza virus A/Victoria/361/2011 (H3N2) – like strain 7.5mcg
Influenza virus B/Brisbane/60/2008 – like strain 7.5mcg
Influenza virus B/Massachusetts/2/2012 – like strain 7.5mcg
Dosage Form:
Suspension for injection
New Zealand Sponsor:
sanofi-aventis new zealand limited
Manufacturer:
Sanofi Pasteur Inc, Pennsylvania, United States of America

Product:
Levoclear
Active Ingredient:
Levocetirizine hydrochloride 5mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
AFT Pharmaceuticals Limited
Manufacturer:
Zakład Farmaceutyczny Adamed Pharma S.A., Ksawerow, Poland

Product:
Xeomin
Active Ingredient/s:
Botulinum toxin type A 50LD50 Units
Dosage Form:
Powder for injection
New Zealand Sponsor:
New Zealand Medical & Scientific Limited
Manufacturers:
Merz Pharma GmbH & Co KGaA, Dessau-Rosslau, Germany
IDT Biologika GmbH, Dessau-Rosslau, Germany

Product:
Xeomin
Active Ingredient:
Botulinum toxin type A 100LD50 Units
Dosage Form:
Powder for injection
New Zealand Sponsor:
New Zealand Medical & Scientific Limited
Manufacturers:
Merz Pharma GmbH & Co KGaA, Dessau-Rosslau, Germany
IDT Biologika GmbH, Dessau-Rosslau, Germany

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 153





✨ LLM interpretation of page content

🏥 Consent to the Distribution of a New Medicine (Eylea)

🏥 Health & Social Welfare
12 December 2014
Medicines Act 1981, Eylea, Aflibercept, Bayer New Zealand Limited, Regeneron Pharmaceuticals Inc
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🏥 Consent to the Distribution of New Medicines (FluQuadri, FluQuadri Junior, Levoclear, Xeomin)

🏥 Health & Social Welfare
Medicines Act 1981, FluQuadri, FluQuadri Junior, Levoclear, Xeomin, sanofi-aventis new zealand limited, AFT Pharmaceuticals Limited, New Zealand Medical & Scientific Limited