Pursuant to section 23 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: Zopine
Active Ingredient: Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Note: This consent is given subject to the following conditions:
? The medicine may only be prescribed by:
- medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branches of psychological medicine or psychiatry;
- medical practitioners employed as registrars in psychological medicine or psychiatry who are under the supervision
of persons of the kind referred to above.
? Persons prescribing the medicine must comply with the requirements of the New Zealand Guidelines for the Use of Atypical Anti-Psychotic Drugs (Second Edition September 1998), and the requirements of local hospital and health service protocols for the use of clozapine.
Note: This consent is valid for two years from 19 October 2004.
Product: Zopine
Active Ingredient: Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Note: This consent is given subject to the following conditions:
? The medicine may only be prescribed by:
- medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branches of psychological medicine or psychiatry;
- medical practitioners employed as registrars in psychological medicine or psychiatry who are under the supervision
of persons of the kind referred to above.
? Persons prescribing the medicine must comply with the requirements of the New Zealand Guidelines for the Use of Atypical Anti-Psychotic Drugs (Second Edition September 1998), and the requirements of local hospital and health service protocols for the use of clozapine.
Note: This consent is valid for two years from 19 October 2004.
Dated this 30th day of August 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).