Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 53 — 9 JUNE 2016

Product:
Neo-Mercazole

Active Ingredient:
Carbimazole 5mg

Dosage Form:
Tablet

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Cenexi SAS, Fontenay-sous-Bois, France

Dated this 2nd day of June 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

2016-go3232

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

Product:
Clopine

Active Ingredient:
Clozapine 25mg

Dosage Form:
Tablet

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Douglas Manufacturing Limited, Auckland, New Zealand

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

  1. The medicine may only be prescribed by:

    • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (“Psychiatrist”).
    • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist.
    • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, or following consultation with, a Community Mental Health Team.
  2. Persons prescribing the medicine must comply with appropriate local treatment guidelines.

  3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines.

  4. Sale or marketing of this medicine may only occur if the sponsor has an appropriate blood monitoring and patient record database in place.

Also note: This renewed consent is valid for two years from 10 July 2016.

Product:
Clopine

Active Ingredient:
Clozapine 50mg

Dosage Form:
Tablet

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Douglas Manufacturing Limited, Auckland, New Zealand

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

  1. The medicine may only be prescribed by:
    • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (“Psychiatrist”).
    • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist.
    • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, or following consultation with, a Community Mental Health Team.


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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 53





✨ LLM interpretation of page content

🏥 Consent to the Distribution of Neo-Mercazole

🏥 Health & Social Welfare
2 June 2016
Medicines, Distribution, Neo-Mercazole, Carbimazole, Medsafe
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🏥 Renewal of Provisional Consent to the Distribution of Clopine

🏥 Health & Social Welfare
Medicines, Renewal, Clopine, Clozapine, Provisional Consent