✨ Medicines Consent Notices




530

NEW ZEALAND GAZETTE

No. 23

Dated this 21st day of February 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 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:
Rescriptor

Active Ingredient(s):
Delavirdine mesylate 100mg equivalent to 82.6mg delavirdine base

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Pfizer Laboratories Limited

Manufacturer(s):
Pharmacia Inc, Barcelonetta, Puerto Rico

Note: This consent is valid for 2 years from the date of publication of this notice.

Dated this 21st day of February 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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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:
Avaxim

Active Ingredient(s):
Hepatitis A virus formaldehyde inactivated (GBM strain) 160U

Dosage Form:
Suspension for injection

New Zealand Sponsor:
CSL (New Zealand) Limited

Manufacturer(s):
Aventis Pasteur SA, Marcy L’Etoile, France

Product:
Biostate

Active Ingredient(s):
Dried factor VIII fraction 250IU

Dosage Form:
Powder for injection

New Zealand Sponsor:
CSL (New Zealand) Limited

Manufacturer(s):
CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia

Product:
Cefazolin Injection

Active Ingredient(s):
Cephazolin sodium 524mg equivalent to 0.5g cefazolin

Dosage Form:
Powder for injection

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Biochemie GmbH, Kundl, Austria

Product:
Cefazolin Injection

Active Ingredient(s):
Cephazolin sodium 1,048mg equivalent to 1g cefazolin

Dosage Form:
Powder for injection

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Biochemie GmbH, Kundl, Austria

Product:
Cefotaxime Sodium for Injection

Active Ingredient(s):
Cefotaxime sodium 1.048g equivalent to 1g cefotaxime

Dosage Form:
Powder for injection

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer(s):
Anfarm Hellas SA, Athens, Greece

Product:
Cefotaxime Sodium for Injection

Active Ingredient(s):
Cefotaxime sodium 2.096g equivalent to 2g cefotaxime

Dosage Form:
Powder for injection

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer(s):
Anfarm Hellas SA, Athens, Greece

Product:
Cefotaxime Sodium for Injection

Active Ingredient(s):
Cefotaxime sodium 525mg equivalent to 500mg cefotaxime

Dosage Form:
Powder for injection

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer(s):
Anfarm Hellas SA, Athens, Greece



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 23


Gazette.govt.nz PDF NZ Gazette 2001, No 23





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
21 February 2001
Medicines, Provisional Consent, Rescriptor, Delavirdine mesylate
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
21 February 2001
Medicines, Consent, Avaxim, Biostate, Cefazolin Injection, Cefotaxime Sodium for Injection
  • G. R. Boyd, Chief Advisor, Safety and Regulation