New Zealand Gazette – 2016 – No. 53

Page 32

✨ Medicines Consent Renewal



NEW ZEALAND GAZETTE, No. 53 — 9 JUNE 2016

  1. Persons prescribing the medicine must comply with appropriate local treatment guidelines.
  2. The medicine must be dispensed in accordance with appropriate local dispensing guidelines.
  3. 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 100mg
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 200mg
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.

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Online Sources for this page:

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




✨ LLM interpretation of page content

🏥 Renewal of Provisional Consent to the Distribution of Clopine (continued from previous page)

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