✨ Medicines Act Notices




NEW ZEALAND GAZETTE

No. 48


Health

Medicines Act 1981

Renewal of 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

Name and Strength Form Name and Address of Manufacturer Proprietary Name (if any)
300 mcg Anti D (Rhβ‚€) Immunoglobulin (> 820IU) Solution for IM injection Ortho Diagnostic Systems Inc., Raritan, New Jersey, United States of America RhoGam

Conditions:

  1. This provisional consent is valid for twelve (12) months from the date of publication of this notice.

  2. The health care professional who prescribes or administers RhoGam must report its use to Auckland Healthcare Limited on a standardised form. The standardised form must contain the name and address of the health care professional and patient, and the reason, place and date of administration.

  3. On a monthly basis, Auckland Healthcare Limited are required to forward the user information forms to the Ministry of Health along with information detailing the amounts of RhoGam distributed and the sites to which it was distributed.

Dated this 10th day of May 1996.

HUGH BABER, Assistant General Manager, Health Regulation and Protection, pursuant to delegation given by the Minister of Health on the 18th day of January 1996.

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Consent to the Distribution of a Changed 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 changed related product which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:

Schedule

Name and Strength Form Name and Address of Manufacturer Proprietary Name (if any)
Sodium fluoride 0.22% w/w Toothpaste Colgate-Palmolive Pty Limited, Labrador, Queensland, Australia Colgate Toothpaste with Baking Soda Gel

Dated this 10th day of May 1996.

HUGH BABER, Assistant General Manager, Health Regulation and Protection, pursuant to delegation given by the Minister of Health on the 18th day of January 1996.

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Consent to the Distribution of a New Medicine

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

Schedule

Name and Strength Form Name and Address of Manufacturer Proprietary Name (if any)
Metformin hydrochloride 500 mg Tablet Apotex Inc., Weston, Ontario, Canada Apo-Metformin
Cetylpyridinium chloride 1.33 mg, pholcodine 5.5 mg Lozenge Barratts Pharmaceuticals Pty Limited, Blacktown, New South Wales, Australia Duro-Tuss Cough Lozenges (orange flavoured)
Diphenhydramine hydrochloride 25 mg, paracetamol 500 mg Tablet SmithKline Beecham (Australia) Pty Limited, Ermington, New South Wales, Australia Panadol Night Time

Dated this 14th day of May 1996.

HUGH BABER, Assistant General Manager, Health Regulation and Protection, pursuant to delegation given by the Minister of Health on the 18th day of January 1996.

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✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
10 May 1996
Medicines Act, Provisional Consent, RhoGam, Anti D Immunoglobulin
  • HUGH BABER, Assistant General Manager, Health Regulation and Protection

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

πŸ₯ Health & Social Welfare
10 May 1996
Medicines Act, Changed Product, Colgate Toothpaste, Sodium fluoride
  • HUGH BABER, Assistant General Manager, Health Regulation and Protection

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
14 May 1996
Medicines Act, New Medicine, Metformin, Cetylpyridinium chloride, Diphenhydramine hydrochloride
  • HUGH BABER, Assistant General Manager, Health Regulation and Protection