2700 NEW ZEALAND GAZETTE, No. 111 2 SEPTEMBER 2004

Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Vaqta Vaccine
Active Ingredient: Hepatitis A vaccine 50U/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Evans Vaccines Limited, Speke, Liverpool, England
Merck & Co Inc, West Point, Pennsylvania, United States of America

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).

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Renewal of 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 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.\n
● 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).

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Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Advil (pharmacy only)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Cardinal Health Australia 401 Pty Limited, Braeside, Victoria, Australia