16 AUGUST 2012 NEW ZEALAND GAZETTE, No. 98 2735

• 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.

Also Note: This renewed consent is valid for two years from 3 June 2012.

Dated this 9th day of August 2012.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Provisional Consent to the Distribution of a New Medicine

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 medicine set out in the Schedule hereto:

Schedule

Product: Fasturtec
Active Ingredient: Rasburicase 1.5mg
Dosage Form: Powder for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Glaxo Wellcome Production, Notre Dame de Bondeville, France
Gruppo Lepetit SRL, Anagni, Italy

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

Dated this 9th day of August 2012.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Aclasta
Active Ingredient: Zoledronic acid monohydrate 0.0533mg/mL equivalent to zoledronic acid 0.05mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Botox®
Active Ingredient: Botulinum A toxin 100U
Dosage Form: Powder for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals Ireland, County Mayo, Ireland

Dated this 9th day of August 2012.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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