2056 NEW ZEALAND GAZETTE, No. 73 10 JULY 2014

Product: Albey Paper Wasp Venom
Active Ingredient: Wasp venom protein 550mcg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Ebos Group Limited
Manufacturers: Stallergenes SA, Antony, France
Jubilant Hollister-Stier LLC, Washington, United States of America

Product: Albey Yellow Jacket Venom
Active Ingredient: Wasp venom protein 550mcg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Ebos Group Limited
Manufacturers: Stallergenes SA, Antony, France
Jubilant Hollister-Stier LLC, Washington, United States of America

Dated this 4th day of July 2014.

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

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 medicine 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 the 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 2014.

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 2014.