Consent to the Distribution of a New Medicine
In the notice published in the New Zealand Gazette, 23 November 2000, No. 157, page 4049, notice No. 8569, the entries in lines 10 to 19 for Clopine tablets are deleted and the following new notice is substituted:
Provisional Consent to the Distribution of a New Medicine
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 medicine (Clopine) described in the Schedule hereto.
This provisional consent has effect for 2 years from 23 November 2000.
This provisional consent is subject to the following conditions:
(i) The medicine may only be prescribed by:
(a) medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branches of psychological medicine or psychiatry; and
(b) medical practitioners employed as registrars in psychological medicine or psychiatry who are under the supervision of persons of the kind referred to in paragraph (a) above.
(ii) 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 use of Clozapine.
Schedule
Product: Clopine
Active Ingredient(s): Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Ltd
Manufacturer(s): Douglas Manufacturing, div. Douglas Pharmaceuticals Ltd, Central Park Drive, Lincoln, Auckland
Product: Clopine
Active Ingredient(s): Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Ltd
Manufacturer(s): Douglas Manufacturing, div. Douglas Pharmaceuticals Ltd, Central Park Drive, Lincoln, Auckland
Dated this 6th day of December 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).