✨ Medicine Distribution Consents




29 MAY 2008 NEW ZEALAND GAZETTE, No. 89

2429

Product:
Active Ingredient:
Carvelol
Carvedilol 3.125mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer:
Specifar SA, Aigaleo, Athens, Greece

Product:
Active Ingredient:
Carvelol
Carvedilol 6.25mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer:
Specifar SA, Aigaleo, Athens, Greece

Product:
Active Ingredients:
Fosamax Plus
Alendronate sodium trihydrate 91.37mg equivalent to 70mg alendronic acid
Colecalciferol 140Β΅g equivalent to 5600 IU
Dosage Form:
Tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer:
MSD Frosst Iberica SA, Alcala de Henares, Madrid, Spain

Product:
Active Ingredient:
Invega
Paliperidone 12mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited
Manufacturer:
Alza Corporation, Vacaville, California, United States of America

Product:
Active Ingredient:
Invega
Paliperidone 3mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited
Manufacturer:
Alza Corporation, Vacaville, California, United States of America

Product:
Active Ingredient:
Invega
Paliperidone 6mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited
Manufacturer:
Alza Corporation, Vacaville, California, United States of America

Product:
Active Ingredient:
Invega
Paliperidone 9mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited
Manufacturer:
Alza Corporation, Vacaville, California, United States of America

Product:
Active Ingredient:
Lantus OptiSet
Insulin glargine 3.6378mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
sanofi-aventis new zealand limited
Manufacturer:
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany

Dated this 27th day of May 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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Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Viramune
Nevirapine hemihydrate 10.35mg/mL equivalent to 10mg/mL nevirapine
Dosage Form:
Oral suspension
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturer:
Boehringer Ingelheim Roxane Inc, Columbus, Ohio, United States of America

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

Dated this 27th day of May 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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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2008, No 89


Gazette.govt.nz PDF NZ Gazette 2008, No 89





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
27 May 2008
Medicines, Distribution, Consent, Carvelol, Fosamax Plus, Invega, Lantus OptiSet
  • ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Renewal of Provisional Consent to the Distribution of a Medicine

πŸ₯ Health & Social Welfare
27 May 2008
Medicines, Distribution, Provisional Consent, Renewal, Viramune
  • ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate