β¨ 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:
-
This provisional consent is valid for twelve (12) months from the date of publication of this notice.
-
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.
-
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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VUW Te Waharoa —
NZ Gazette 1996, No 48
NZLII —
NZ Gazette 1996, No 48
β¨ LLM interpretation of page content
π₯ Renewal of Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare10 May 1996
Medicines Act, Provisional Consent, RhoGam, Anti D Immunoglobulin
- HUGH BABER, Assistant General Manager, Health Regulation and Protection
π₯ Consent to the Distribution of a Changed Related Product
π₯ Health & Social Welfare10 May 1996
Medicines Act, Changed Product, Colgate Toothpaste, Sodium fluoride
- HUGH BABER, Assistant General Manager, Health Regulation and Protection
π₯ Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare14 May 1996
Medicines Act, New Medicine, Metformin, Cetylpyridinium chloride, Diphenhydramine hydrochloride
- HUGH BABER, Assistant General Manager, Health Regulation and Protection