✨ Medicine Distribution Consents




4096 NEW ZEALAND GAZETTE, No. 164 2 DECEMBER 2010

Product:
Noradrenaline Tartrate

Active Ingredient:
Noradrenaline acid tartrate monohydrate 0.199g/L equivalent to 0.1g noradrenaline base

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Biomed Limited

Manufacturer:
Biomed Limited, Auckland, New Zealand

Note: This consent is valid for two years from the date of publication of this notice.

Product:
Noradrenaline Tartrate

Active Ingredient:
Noradrenaline acid tartrate monohydrate 0.239g/L equivalent to 0.12g noradrenaline base

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Biomed Limited

Manufacturer:
Biomed Limited, Auckland, New Zealand

Note: This consent is valid for two years from the date of publication of this notice.

Product:
Noradrenaline Tartrate

Active Ingredient:
Noradrenaline acid tartrate monohydrate 0.319g/L equivalent to 0.16g noradrenaline base

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Biomed Limited

Manufacturer:
Biomed Limited, Auckland, New Zealand

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 26th day of November 2010.

JANICE WILSON, Deputy Director-General, Population Health Directorate, 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:
Cefazolin-AFT

Active Ingredient:
Cefazolin sodium 540mg equivalent to 500mg cefazolin

Dosage Form:
Powder for injection

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Medochemie Limited, Limassol, Cyprus

Product:
Cefazolin-AFT

Active Ingredient:
Cefazolin sodium 1.08g equivalent to 1g cefazolin

Dosage Form:
Powder for injection

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Medochemie Limited, Limassol, Cyprus

Product:
Cerezyme

Active Ingredient:
Imiglucerase-rch 400U

Dosage Form:
Powder for infusion

New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics

Manufacturers:
Genzyme Ireland Limited, Waterford, Ireland
Bionique Testing Laboratories, Saranac Lake, United States of America
BioReliance Testing and Development, Incorporated, Rockville, United States of America

Product:
Ibuprofen Liquid Capsules

Active Ingredient:
Ibuprofen 200mg

Dosage Form:
Liquid filled capsule

New Zealand Sponsor:
Multichem NZ Limited

Manufacturer:
Geltec Private Limited, Bangalore, India

Product:
Ismo 40 Retard

Active Ingredient:
Isosorbide mononitrate 40mg

Dosage Form:
Modified release tablet

New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics

Manufacturer:
Kern Pharma SL, Barcelona, Spain

Product:
Naltraccord

Active Ingredient:
Naltrexone hydrochloride 50mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Accord Healthcare NZ Limited

Manufacturer:
Intas Pharmaceuticals Limited, Ahmedabad, India



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 164





✨ LLM interpretation of page content

πŸ₯ Provisional Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
26 November 2010
Medicines, Provisional Consent, Noradrenaline Tartrate, Biomed Limited
  • JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Consent, Cefazolin-AFT, Cerezyme, Ibuprofen Liquid Capsules, Ismo 40 Retard, Naltraccord