✨ Health Notices




15 MARCH

NEW ZEALAND GAZETTE

621

Health

Medicines Act 1981

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: SBPA Clozapine 100
Active Ingredient(s): Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany

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 2 years from the date of publication of this notice.

Product: SBPA Clozapine 25
Active Ingredient(s): Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany

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 2 years from the date of publication of this notice.

Dated this 7th day of March 2001.

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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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: Atehexal
Active Ingredient(s): Atenolol 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Hexal New Zealand Pty Limited
Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany
Salutas Pharma GmbH, Barleben, Germany

Product: Atehexal
Active Ingredient(s): Atenolol 50
Dosage Form: Film coated tablet
New Zealand Sponsor: Hexal New Zealand Pty Limited
Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany
Salutas Pharma GmbH, Barleben, Germany



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 28


Gazette.govt.nz PDF NZ Gazette 2001, No 28





✨ LLM interpretation of page content

πŸ₯ Provisional Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
7 March 2001
Medicines, Provisional Consent, Clozapine, SBPA Clozapine 100, SBPA Clozapine 25, Novartis, Rottendorf Pharma, Psychological Medicine, Psychiatry
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Consent, Atehexal, Atenolol, Hexal New Zealand, Rottendorf Pharma, Salutas Pharma