Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

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 set out in the Schedule hereto:

Schedule

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:

  • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (hereinafter referred to as a Psychiatrist)
  • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist
  • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, 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 2020.
   
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:

  • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (hereinafter referred to as a Psychiatrist)
  • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist
  • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, 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 2020.
 
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:

  • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (hereinafter referred to as a Psychiatrist)
  • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist
  • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, 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 2020.
   
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:

  • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (hereinafter referred to as a Psychiatrist)
  • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist
  • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, 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 2020.
 
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:

  • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (hereinafter referred to as a Psychiatrist)
  • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist
  • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, 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 2020.
   
Product: Clozaril
Active Ingredient: Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: 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:

  • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (hereinafter referred to as a Psychiatrist)
  • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist
  • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, 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 2020.
 
Product: Clozaril
Active Ingredient: Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: 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:

  • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (hereinafter referred to as a Psychiatrist)
  • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist
  • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, 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 2020.
   
Product: PiperTaz Sandoz
Active Ingredients: Piperacillin monohydrate 4.198g equivalent to piperacillin sodium 4.2531g equivalent to piperacillin 4.0g
Tazobactam 0.5g equivalent to tazobactam sodium 0.54733g
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz GmbH, Kundl, Austria
Note: This consent is given subject to the following conditions:
  • Provisional consent is to be granted for 1 year to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other comparable piperacillin/tazobactam medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This renewed consent is valid for one year from 6 August 2020.


Dated this 6th day of July 2020.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).