Medicines Act Notices




3514

NEW ZEALAND GAZETTE

No. 131

Health

Medicines Act 1981

Consent to the Distribution of a New Medicine

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

Schedule

Product: Bion Tears

Active Ingredients: Dextran 70 0.1%w/v

Hypromellose 0.3%w/v

Dosage Form: Eye drops, solution

New Zealand Sponsor: Pacific Pharmaceuticals Limited

Manufacturer: Laboratoires Alcon S.A., Ferrenbach, Kaysersberg, France

Dated this 28th day of August 2002.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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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: Clopine

Active Ingredient: Clozapine 100mg

Dosage Form: Tablet

New Zealand Sponsor: Douglas Pharmaceuticals Limited

Manufacturer: Douglas Manufacturing (a division of Douglas Pharmaceuticals Limited), Lincoln, Auckland

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 (2nd 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 2002.

Product: Clopine

Active Ingredient: Clozapine 25mg

Dosage Form: Tablet

New Zealand Sponsor: Douglas Pharmaceuticals Limited

Manufacturer: Douglas Manufacturing (a division of Douglas Pharmaceuticals Limited), Lincoln, Auckland

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 (2nd 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 2002.

Dated this 28th day of August 2002.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2002, No 131


Gazette.govt.nz PDF NZ Gazette 2002, No 131





✨ LLM interpretation of page content

🏥 Consent to Distribution of New Medicine

🏥 Health & Social Welfare
28 August 2002
Medicines, Distribution, Bion Tears, Eye drops
  • G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Renewal of Provisional Consent for Medicine

🏥 Health & Social Welfare
28 August 2002
Medicines, Provisional Consent, Clopine, Clozapine
  • G. R. Boyd, Chief Advisor, Safety and Regulation