✨ Medicines Distribution Consents




4176

NEW ZEALAND GAZETTE

No. 170

Consent to the Distribution of a New Related Product

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new related product set out in the Schedule hereto:

Schedule

Product: Choice Minty Fresh Toothpaste with Fluoride
Active Ingredient(s): Sodium monofluorophosphate 0.76%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Yummy Confectionery Imports
Manufacturer(s): Choice Laboratories, Unjha (NG), India

Product: Choice Regular Toothpaste with Fluoride
Active Ingredient(s): Sodium monofluorophosphate 0.76%
Dosage Form: Toothpaste
New Zealand Sponsor: Yummy Confectionery Imports
Manufacturer(s): Choice Laboratories, Unjha (NG), India

Product: Pearl Dent Baking Soda Gel Toothpaste with Fluoride
Active Ingredient(s): Sodium monofluorophosphate 0.76%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Yummy Confectionery Imports
Manufacturer(s): Choice Laboratories, Unjha (NG), India

Product: Pearl Dent Fresh Mint Toothpaste with Fluoride
Active Ingredient(s): Sodium monofluorophosphate 0.76%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Yummy Confectionery Imports
Manufacturer(s): Choice Laboratories, Unjha (NG), India

Product: Pearl Dent Regular Toothpaste with Fluoride
Active Ingredient(s): Sodium monofluorophosphate 0.76%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Yummy Confectionery Imports
Manufacturer(s): Choice Laboratories, Unjha (NG), India

Product: Pearl Dent Tartar Control Toothpaste with Fluoride
Active Ingredient(s): Sodium monofluorophosphate 0.76%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Yummy Confectionery Imports
Manufacturer(s): Choice Laboratories, Unjha (NG), India

Dated this 5th day of December 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:

Product: BayHep B
Active Ingredient(s): Hepatitis B immunoglobulin (human) 217IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited Health Care Division
Manufacturer(s): Bayer Corporation, 8368 U.S. 70 West, Clayton, North Carolina 27250, United States of America

This consent is given subject to the following conditions:

  • Provisional consent under section 23 of the Medicines Act 1981 will only be valid for a period of 2 years.
  • Other conditions may be imposed from time to time by the Director-General of Health in respect to the supply, distribution and use of this medicine.

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

Dated this 5th day of December 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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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 170


Gazette.govt.nz PDF NZ Gazette 2001, No 170





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a New Related Product

πŸ₯ Health & Social Welfare
5 December 2001
Medicines Act, Distribution Consent, Toothpaste, Sodium monofluorophosphate, Yummy Confectionery Imports, Choice Laboratories, Pearl Dent
  • G. R. Boyd, Chief Advisor, Safety and Regulation

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

πŸ₯ Health & Social Welfare
5 December 2001
Medicines Act, Provisional Consent, BayHep B, Hepatitis B immunoglobulin, Bayer New Zealand Limited, Bayer Corporation
  • G. R. Boyd, Chief Advisor, Safety and Regulation