✨ Medicines Notices




1450 NEW ZEALAND GAZETTE, No. 52 6 MAY 2010

Medicines Act 1981

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) 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: Abelcet
Active Ingredient: Amphotericin B 5mg/mL
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Enzon Pharmaceuticals, Inc, Indianapolis, United States of America

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

Dated this 29th day of April 2010.

ANTHONY HILL, Deputy Director-General, Regulation and Governance 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: Loxalate
Active Ingredient: Escitalopram oxalate 25.56mg equivalent to escitalopram 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia

Product: Loxalate
Active Ingredient: Escitalopram oxalate 12.78mg equivalent to escitalopram 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia

Product: Loxalate
Active Ingredient: Escitalopram oxalate 6.39mg equivalent to escitalopram 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia

Product: Apo-Atorvastatin
Active Ingredient: Atorvastatin calcium 11mg equivalent to atorvastatin 10mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada

Product: Apo-Atorvastatin
Active Ingredient: Atorvastatin calcium 22mg equivalent to atorvastatin 20mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada

Product: Apo-Atorvastatin
Active Ingredient: Atorvastatin calcium 44mg equivalent to atorvastatin 40mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada

Product: Apo-Atorvastatin
Active Ingredient: Atorvastatin calcium 88mg equivalent to atorvastatin 80mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 52





✨ LLM interpretation of page content

πŸ₯ Provisional Consent to Distribute New Medicine

πŸ₯ Health & Social Welfare
29 April 2010
Medicines Act, Provisional Consent, Abelcet, Amphotericin B
  • ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Consent to Distribute New Medicines

πŸ₯ Health & Social Welfare
Medicines Act, Consent, Loxalate, Apo-Atorvastatin