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 medicines subject to the following amended conditions 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 the persons referred to above.
- 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.
- 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 a 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; 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 renewed 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, 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 the persons referred to above.
- 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.
- 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 a 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; 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 renewed consent is valid for two years from the date of publication of this notice.
Product: Clopine
Active Ingredient: Clozapine 100mg
Dosage Form: Tablet
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 the persons referred to above.
- 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.
- 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 a 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; 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 renewed consent is valid for two years from the date of publication of this notice.
Product: Clopine
Active Ingredient: Clozapine 50mg
Dosage Form: Tablet
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 the persons referred to above.
- 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.
- 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 a 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; 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 renewed 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, 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 the persons referred to above.
- 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.
- 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 a 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; 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 renewed 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, Horsham, 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 the persons referred to above.
- 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.
- 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 a 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; 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 renewed consent is valid for two years from the date of publication of this notice.
Product: Clozaril
Active Ingredient: Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharmaceuticals UK Limited, Horsham, 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 the persons referred to above.
- 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.
- 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 a 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; 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 renewed consent is valid for two years from the date of publication of this notice.
Product: Zopine
Active Ingredient: Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
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 the persons referred to above.
- 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.
- 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 a 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; 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 renewed consent is valid for two years from the date of publication of this notice.
Product: Zopine
Active Ingredient: Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
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 the persons referred to above.
- 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.
- 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 a 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; 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 renewed consent is valid for two years from the date of publication of this notice.
Dated this 31st day of May 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).