Medicine Distribution Consents




3036 NEW ZEALAND GAZETTE, No. 103 31 AUGUST 2006

● Persons prescribing the medicine must comply with the requirements of the New Zealand Guidelines for the Use of Atypical Anti-Psychotic Drugs (Third Edition January 2002), and the requirements of local hospital and health service protocols for the use of clozapine.

Note: This consent is valid for two years from 13 January 2007.

Product: Clopine
Active Ingredient: Clozapine 50mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Lincoln, Auckland

Note: This consent is given subject to the following conditions:

● The medicine may only be prescribed by:
– medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branches of psychological medicine or psychiatry;
– medical practitioners employed as registrars in psychological medicine or psychiatry who are under the supervision of persons of the kind referred to above.

● Persons prescribing the medicine must comply with the requirements of the New Zealand Guidelines for the Use of Atypical Anti-Psychotic Drugs (Third Edition January 2002), and the requirements of local hospital and health service protocols for the use of clozapine.

Note: This consent is valid for two years from 13 January 2007.

Dated this 28th day of August 2006.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine 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

Product: Plavix
Active Ingredient: Clopidogrel hydrogen sulphate, 97.875mg equivalent to 75mg Clopidogrel
Dosage Form: Film coated tablet
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturers: Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Sanofi Winthrop Industrie, Ambares, France
Sanofi-Synthelabo Limited, Fawdon, Newcastle-upon-Tyne, Tyne & Wear, United Kingdom

Dated this 28th day of August 2006.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Consent to the Distribution of New Medicines

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

Schedule

Product: Colpocin-T
Active Ingredient: Metronidazole 5mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA, Kryoneri, Athens, Greece

Product: Luxotine
Active Ingredient: Paroxetine hydrochloride 22.21mg equivalent to paroxetine 20mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Sandoz Pharmaceuticals GmbH, Gerlingen, Germany

Product: m-Doxazosin
Active Ingredient: Doxazosin mesilate 1.213mg equivalent to doxazosin 1mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Dexcel Limited, Or Akiva, Israel



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2006, No 103


Gazette.govt.nz PDF NZ Gazette 2006, No 103





✨ LLM interpretation of page content

🏥 Renewal of Provisional Consent to the Distribution of a New Medicine (continued from previous page)

🏥 Health & Social Welfare
28 August 2006
Medicine Consent, Clopine, Clozapine, Douglas Pharmaceuticals, Psychiatric Medication
  • DON MATHESON, Deputy Director-General, Public Health

🏥 Consent to the Distribution of a Changed Medicine

🏥 Health & Social Welfare
28 August 2006
Medicine Consent, Plavix, Clopidogrel, Sanofi-Aventis, Bristol-Myers Squibb
  • DON MATHESON, Deputy Director-General, Public Health

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
28 August 2006
Medicine Consent, Colpocin-T, Metronidazole, Luxotine, Paroxetine, m-Doxazosin, Doxazosin
  • DON MATHESON, Deputy Director-General, Public Health