✨ Medicines Distribution Consents




NEW ZEALAND GAZETTE

No. 102

2796

Product:
Risperdal Consta

Active Ingredient:
Risperidone 25mg

Dosage Form:
Vial Powder for injection

New Zealand Sponsor:
Janssen-Cilag Pty Limited

Manufacturer:
Alkermes, Wilmington, Ohio, United States of America

Product:
Risperdal Consta

Active Ingredient:
Risperidone 37.5mg

Dosage Form:
Vial Suspension for injection

New Zealand Sponsor:
Janssen-Cilag Pty Limited

Manufacturer:
Alkermes, Wilmington, Ohio, United States of America

Product:
Risperdal Consta

Active Ingredient:
Risperidone 50mg

Dosage Form:
Vial Suspension for injection

New Zealand Sponsor:
Janssen-Cilag Pty Limited

Manufacturer:
Alkermes, Wilmington, Ohio, United States of America

Dated this 7th 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:
Zopine

Active Ingredient:
Clozapine 100mg

Dosage Form:
Tablet

New Zealand Sponsor:
Pacific Pharmaceuticals Limited

Manufacturer:
Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia

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.\n- 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 19 October 2002.

Product:
Zopine

Active Ingredient:
Clozapine 25mg

Dosage Form:
Tablet

New Zealand Sponsor:
Pacific Pharmaceuticals Limited

Manufacturer:
Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia

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.\n- 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 19 October 2002.

Dated this 7th 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 102


Gazette.govt.nz PDF NZ Gazette 2002, No 102





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
7 August 2002
Medicines, Approval, Distribution, Risperdal Consta, Janssen-Cilag, Alkermes
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
7 August 2002
Medicines, Provisional Consent, Renewal, Zopine, Clozapine, Pacific Pharmaceuticals, Alphapharm
  • G. R. Boyd, Chief Advisor, Safety and Regulation