Medicines Distribution Consents




4434 NEW ZEALAND GAZETTE, No. 169 6 NOVEMBER 2008

Product: Synthroid
Active Ingredient: Levothyroxine sodium, anhydrous 300µg
Dosage Form: Tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott Laboratories Inc, Puerto Rico, United States of America

Product: Synthroid
Active Ingredient: Levothyroxine sodium, anhydrous 50µg
Dosage Form: Tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott Laboratories Inc, Puerto Rico, United States of America

Product: Synthroid
Active Ingredient: Levothyroxine sodium, anhydrous 75µg
Dosage Form: Tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott Laboratories Inc, Puerto Rico, United States of America

Product: Synthroid
Active Ingredient: Levothyroxine sodium, anhydrous 88µg
Dosage Form: Tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott Laboratories Inc, Puerto Rico, United States of America

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

Dated this 31st day of October 2008.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (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: Amlodipine
Active Ingredient: Amlodipine besilate 13.888mg equivalent to 10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Airflow Products Limited
Manufacturer: Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary

Product: Amlodipine
Active Ingredient: Amlodipine besilate 6.944mg equivalent to amlodipine 5mg
Dosage Form: Tablet
New Zealand Sponsor: Airflow Products Limited
Manufacturer: Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary

Product: Cathejell
Active Ingredients: Chlorhexidine hydrochloride 0.05%w/w
Lidocaine 2%w/w
Dosage Form: Topical gel
New Zealand Sponsor: USL Medical Consumer Products
Manufacturer: Montavit GmbH, Absam, Tirol, Austria

Product: Emnorm
Active Ingredient: Metformin hydrochloride 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India

Product: Emnorm
Active Ingredient: Metformin hydrochloride 850mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2008, No 169





✨ LLM interpretation of page content

🏥 Corrigendum to Medicines Act 1981 Consent (continued from previous page)

🏥 Health & Social Welfare
Medicines Act, Corrigendum, Medicine Distribution, Provisional Consent

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
31 October 2008
Medicines Act, Medicine Distribution, Consent, Synthroid, Amlodipine, Cathejell, Emnorm
  • ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate