8 MAY 2014 NEW ZEALAND GAZETTE, No. 46 1337

Schedule

Product: Nexavar
Active Ingredient: Sorafenib tosilate 274mg equivalent to Sorafenib 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Healthcare Manufacturing Srl, Milano, Italy
Bayer Pharma AG, Leverkusen, Germany

Product: Remicade
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Schering-Plough Company, County Cork, Ireland
Cilag AG, Schaffhausen, Switzerland
Patheon Italia SpA, Milan, Italy
MSD International GmbH (Singapore Branch), Singapore

Dated this 1st day of May 2014.

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

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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:

   • 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 the persons referred to above.
   • Medical Officers who 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.

Note: This renewed consent is valid for two years from 3 June 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:
   • 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 the persons referred to above.
   • Medical Officers who 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.