NEW ZEALAND GAZETTE, No. 100

19 JUNE 2008

Schedule

Product: Avastin
Active Ingredient: Bevacizumab 100mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Genentech Inc, South San Francisco, California, United States of America

Product: Xeloda
Active Ingredient: Capecitabine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited, t/a Roche Consumer Health, Welwyn Garden City, Hertfordshire, United Kingdom

Product: Xeloda
Active Ingredient: Capecitabine 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited, t/a Roche Consumer Health, Welwyn Garden City, Hertfordshire, United Kingdom

Dated this 12th day of June 2008.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews provisional consent to the sale, supply or use in New Zealand of the medicine 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, Lincoln, Auckland

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 persons of the kind referred to above; and
   • 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.

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 means further use is contraindicated.

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

Dated this 12th day of June 2008.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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