3728 NEW ZEALAND GAZETTE, No. 149 18 NOVEMBER 2004

Schedule

Product:
Clopine

Active Ingredient:
Clozapine 100mg

Dosage Form:
Tablet

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Douglas Pharmaceuticals Limited, 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 23 November 2004.

Product:
Clopine

Active Ingredient:
Clozapine 25mg

Dosage Form:
Tablet

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Douglas Pharmaceuticals Limited, 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 23 November 2004.

Dated this 16th day of November 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 Changed Medicines

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

Schedule

Product:
Hyzaar

Active Ingredients:
Hydrochlorothiazide 12.5mg
Losartan potassium 50mg

Dosage Form:
Tablet

New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited

Manufacturers:
Bristol-Myers Squibb Pharma Company, Garden City, New York, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom

Product:
Remicade (notification received 26 August 2003)

Active Ingredient:
Infliximab 100mg

Dosage Form:
Powder for infusion concentrate

New Zealand Sponsor:
Schering-Plough Animal Health Limited

Manufacturers:
Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Stucchi, Monza, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland

Product:
Remicade (notification received 7 April 2004)

Active Ingredient:
Infliximab 100mg

Dosage Form:
Powder for infusion concentrate

New Zealand Sponsor:
Schering-Plough Animal Health Limited

Manufacturers:
Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Stucchi, Monza, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland