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:

Schedule

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. Clozapine may only be initiated and prescribed by:
    • Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry (i.e. psychiatrists).
    • Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
    • Medical officers who are in the employment of Health New Zealand - Te Whatu Ora, and are under the supervision of persons who are registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry.
    • Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are registered with the Medical Council of New Zealand within the vocational scope of practice of general practice. The general practitioner must be continuing the prescribing of clozapine for a specific patient whose illness is well controlled in collaboration, or following consultation, with the relevant 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 14 May 2024.


Dated this 6th day of May 2024.

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