|
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 (i.e. psychiatrists).
- Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
- Medical officers who are in the employment of a Te Whatu Ora, 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.
|
|
Note: This renewed consent is valid for two years from 10 July 2024.
|
| |
|
|
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 (i.e. psychiatrists).
- Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
- Medical officers who are in the employment of a Te Whatu Ora, 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.
|
|
Note: This renewed consent is valid for two years from 10 July 2024.
|
| |
|
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 (i.e. psychiatrists).
- Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
- Medical officers who are in the employment of a Te Whatu Ora, 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.
|
|
Note: This renewed consent is valid for two years from 10 July 2024.
|
| |
|
|
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 (i.e. psychiatrists).
- Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
- Medical officers who are in the employment of a Te Whatu Ora, 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.
|
|
Note: This renewed consent is valid for two years from 10 July 2024.
|
| |
|
|
Product:
|
Clozaril
|
|
Active Ingredient:
|
Clozapine 25mg
|
|
Dosage Form:
|
Tablet
|
|
New Zealand Sponsor:
|
Viatris Limited
|
|
Manufacturers:
|
Madaus GmbH, Troisdorf, Germany
Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey
McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Dublin, Ireland
|
|
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 (i.e. psychiatrists).
- Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
- Medical officers who are in the employment of a Te Whatu Ora, 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.
|
|
Note: This renewed consent is valid for two years from 10 July 2024.
|
| |
|
|
Product:
|
Clozaril
|
|
Active Ingredient:
|
Clozapine 100mg
|
|
Dosage Form:
|
Tablet
|
|
New Zealand Sponsor:
|
Viatris Limited
|
|
Manufacturers:
|
Madaus GmbH, Troisdorf, Germany
Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey
McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Dublin, Ireland
|
|
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 (i.e. psychiatrists).
- Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
- Medical officers who are in the employment of a Te Whatu Ora, 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.
|
|
Note: This renewed consent is valid for two years from 10 July 2024.
|