✨ 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 PDF NZ Gazette 1998, No 200


NZLII PDF NZ Gazette 1998, No 200





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Changed Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
8 December 1998
Medicines, Distribution, Temozolomide, Temodal, Zodol
  • G. R. Boyd, Chief Advisor, Regulation and Safety

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
11 December 1998
Medicines, Distribution, Cephamandole nafate, Tolterodine L-tartrate, Diltiazem hydrochloride, Clopidogrel hydrogen sulfate, Zolpidem Hemitatrate
  • G. R. Boyd, Chief Advisor, Regulation and Safety

πŸ₯ Revocation of Consent to the Distribution of a Medicine

πŸ₯ Health & Social Welfare
11 December 1998
Medicines, Revocation, Tolcapone, Tasmar
  • Hon. Tuariki John Delamere, Associate Minister of Health

πŸ₯ Provisional Consent to the Distribution of a Medicine

πŸ₯ Health & Social Welfare
11 December 1998
Medicines, Provisional Consent, Tolcapone, Tasmar
  • G. R. Boyd, Chief Advisor, Regulation and Safety