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: Clopine
Active Ingredient: Clozapine 50mg/mL
Dosage Form: Oral suspension
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:
- 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;
- medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of persons of the kind referred to above; and
- medical officers of special scale who:
- work solely in the field of psychiatry;
- are in the employment of a district health board; 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.
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; and
- the sponsor creates or participates in a central "red flag" database identifying patients who have previously been prescribed clozapine and who developed adverse drug reactions, which means further use is contraindicated.
Note: This renewed consent is valid until 19 June 2012.
Dated this 5th day of March 2010.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).