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 medicines set out in the Schedule hereto:
Schedule
Product: Conthram Forte
Active Ingredient(s): Danthron 15mg/mL
Poloxamer 188 200mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
Note: This consent is valid for 2 years from the date of publication of this notice.
This consent is given subject to the following condition:
This medicine may only be used for the prevention or treatment of constipation in the terminally ill.
Product: Conthram
Active Ingredient(s): Danthron 5mg/mL
Poloxamer 188 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
Note: This consent is valid for 2 years from the date of publication of this notice.
This consent is given subject to the following condition:
This medicine may only be used for the prevention or treatment of constipation in the terminally ill.
Product: Zopine
Active Ingredient(s): Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Note: This consent is valid for 2 years from the date of publication of this notice.
This consent is given 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 the use of clozapine.
Product: Zopine
Active Ingredient(s): Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Note: This consent is valid for 2 years from the date of publication of this notice.
This consent is given 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 the use of clozapine.
Dated this 11th day of October 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).