2278 NEW ZEALAND GAZETTE, No. 84 15 MAY 2008

Schedule

Product: Clopine
Active Ingredients: Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Lincoln, Auckland

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 mean further use is contraindicated.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Clopine
Active Ingredient: Clozapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Lincoln, Auckland.

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 mean further use is contraindicated.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Clopine
Active Ingredient: Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Lincoln, Auckland

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