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: SBPA Clozapine 100
Active Ingredient(s): Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany
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; and
? 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 (2nd Edition September 1998) and the requirements of local Hospital and Health Service Protocols for the use of clozapine.
Note: This consent is valid for 2 years from the date of publication of this notice.
Product: SBPA Clozapine 25
Active Ingredient(s): Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany
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; and
? 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 (2nd Edition September 1998) and the requirements of local Hospital and Health Service Protocols for the use of clozapine.
Note: This consent is valid for 2 years from the date of publication of this notice.
Dated this 7th day of March 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).