Notice Type
Notice Title

Renewal of Provisional Consent to the Distribution of a Medicine

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 medicine set out in the Schedule hereto:


Product: Versacloz
Active Ingredient: Clozapine 50mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Pharmaceutics International Inc, Maryland, United States of America

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 (hereinafter referred to as a 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.

Note: This renewed consent is valid for two years from 14 May 2022.

Dated this 13th day of May 2022.

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