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: Clopine
Active Ingredient: Clozapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals Limited, Central Park Drive, Lincoln, Auckland
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; 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 (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 the date of publication of this notice.
Product: Clopine
Active Ingredient: Clozapine 50mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals Limited, Central Park Drive, Lincoln, Auckland
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; 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 (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 the date of publication of this notice.
Product: Reyataz
Active Ingredient: Atazanavir sulfate 113.9mg equivalent to 100mg atazanavir
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Note: This consent is valid for two years from the date of publication of this notice.
Product: Reyataz
Active Ingredient: Atazanavir sulfate 170.84mg equivalent to 150mg atazanavir
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Note: This consent is valid for two years from the date of publication of this notice.
Product: Reyataz
Active Ingredient: Atazanavir sulfate 227.79mg equivalent to 200mg atazanavir
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 6th day of January 2005.
BARRY BORMAN, acting as Deputy Director-General, Public Health, for the period 5 January 2005 to 24 January 2005 (pursuant to delegation given by the Minister of Health on 6 July 2001).