Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new 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, Lincoln, Auckland
Note: This consent is given subject to the following conditions:
? 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; and
– medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of persons of the kind referred to above.
? Persons prescribing the medicine must comply with appropriate local treatment guidelines.
? The medicine must be dispensed in accordance with appropriate local dispensing guidelines.
? 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 mean further use is contraindicated.
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 23rd day of August 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).