NEW ZEALAND GAZETTE, No. 60
27 MAY 2010

Provisional Consent to the Distribution of New Medicines

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Clozaril
Active Ingredient: Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharmaceuticals UK Limited, West Sussex, United Kingdom

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: Clozaril
Active Ingredient: Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharmaceuticals UK Limited, West Sussex, United Kingdom

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: Exjade
Active Ingredient: Deferasirox 125mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

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