β¨ Medicine Distribution Notices
17 DECEMBER NEW ZEALAND GAZETTE 4763
Schedule
| Name and Strength | Form | Name and Address of Manufacturer | Proprietary Name (if any) |
|---|---|---|---|
| Temozolomide 5 mg, 20 mg, 100 mg, 250 mg | Capsules | College of Pharmacy, University of Iowa, Iowa City, Iowa, United States of America | Temodal |
| Temozolomide 5 mg, 20 mg, 100 mg, 250 mg | Capsules | College of Pharmacy, University of Iowa, Iowa City, Iowa, United States of America | Zodol |
Note: This consent is valid for 2 years from the date of publication of this notice.
Dated this 8th day of December 1998.
G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.
g08911
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) |
|---|---|---|---|
| Cephamandole nafate 500 mg, 1 g | Injection, powder | Biopharma Srl., S. Palomba, Rome, Italy and IBSA SA., Lugano, Switzerland | Cefamadole Nafate |
| Tolterodine L-tartrate 1 mg, 2 mg | Tablets, film coated | Pharmacia & Upjohn SpA., Marino del Tronto, Italy | Detrusitol |
| Diltiazem hydrochloride 60 mg | Tablet, film coated | Hexal-Pharma GmbH., Holzkirchen, Germany and Salutas Pharma GmbH., Barleben | Diltahexal |
| Clopidogrel hydrogen sulfate 97.875 mg equivalent to 75 mg clopidogrel free base | Tablet, film coated | Sanofi Winthrop Industrie, Ambares, France | Plavix |
| Zolpidem Hemitatrate 5 mg, 10 mg | Tablets, film coated | Synthelabo Groupe, Tours Cedex, France | Stilnoct |
Dated this 11th day of December 1998.
G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.
g08999
Revocation of Consent to the Distribution of a Medicine
Pursuant to section 35 of the Medicines Act 1981, the Minister of Health hereby revokes the consent granted under section 20 of the Act to the distribution in New Zealand of the medicine set out in the Schedule below:
Schedule
| Name and Strength | Form | Name and Address of Manufacturer | Proprietary Name (if any) |
|---|---|---|---|
| Tolcapone 100 mg, 200 mg | Tablet, film coated | F Hoffmann-La Roche Limited, Basle, Switzerland | Tasmar |
Dated this 11th day of December 1998.
HON. TUARIKI JOHN DELAMEARE, Associate Minister of Health.
g09000
Provisional Consent to the Distribution of a 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 medicine set out in the Schedule below:
Schedule
| Name and Strength | Form | Name and Address of Manufacturer | Proprietary Name (if any) |
|---|---|---|---|
| Tolcapone 100 mg, 200 mg | Tablet, film coated | F Hoffmann-La Roche Limited, Basle, Switzerland | Tasmar |
Note: This consent is valid for 2 years from the date of publication of this notice.
This consent is given subject to the following conditions:
(i) The medicine is prescribed only by medical practitioners vocationally registered under the Medical Practitioners Act 1995 in the branch of internal medicine;
(ii) Patients receiving the medicine undergo baseline liver function tests, followed by fortnightly tests for the first 3 months of treatment and 4-weekly tests thereafter;
Next Page →
PDF embedding disabled (Crown copyright)
View this page online at:
VUW Te Waharoa —
NZ Gazette 1998, No 200
NZLII —
NZ Gazette 1998, No 200
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of Changed Medicines
(continued from previous page)
π₯ Health & Social Welfare8 December 1998
Medicines, Distribution, Temozolomide, Temodal, Zodol
- G. R. Boyd, Chief Advisor, Regulation and Safety
π₯ Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare11 December 1998
Medicines, Distribution, Cephamandole nafate, Tolterodine L-tartrate, Diltiazem hydrochloride, Clopidogrel hydrogen sulfate, Zolpidem Hemitatrate
- G. R. Boyd, Chief Advisor, Regulation and Safety
π₯ Revocation of Consent to the Distribution of a Medicine
π₯ Health & Social Welfare11 December 1998
Medicines, Revocation, Tolcapone, Tasmar
- Hon. Tuariki John Delamere, Associate Minister of Health
π₯ Provisional Consent to the Distribution of a Medicine
π₯ Health & Social Welfare11 December 1998
Medicines, Provisional Consent, Tolcapone, Tasmar
- G. R. Boyd, Chief Advisor, Regulation and Safety