New Zealand Gazette – 2001 – No. 41

Page 915

✨ Medicines Consent Notices

19 APRIL

NEW ZEALAND GAZETTE

915

Product:
Infanrix-penta

Active Ingredient(s):
Adsorbed tetanus vaccine 40IU/dose
Diphtheria toxoid (adsorbed) 30IU/dose
Hepatitis B surface antigen (recombinant) 10µg/dose
Pertussis 69kDa outer membrane protein (Pertactin) 8µg/dose
Pertussis filamentous haemagglutinin 25µg/dose
Pertussis toxoid (adsorbed) 25µg/dose
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU

Dosage Form:
Suspension for injection

New Zealand Sponsor:
SmithKline Beecham (NZ) Limited

Manufacturer(s):
SmithKline Beecham Biologicals SA, Rixensart, Belgium

Product:
Miacalcic 200 IU Nasal Spray

Active Ingredient(s):
Salcatonin 200IU/dose

Dosage Form:
Solution for inhalation

New Zealand Sponsor:
Novartis New Zealand Ltd

Manufacturer(s):
MIPHARM S.p.A, Milano, Italy
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma SA, Huningue, France

Dated this 11th day of April 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).

go2750

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:
Clozaril

Active Ingredient(s):
Clozapine 100mg

Dosage Form:
Tablet

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Novartis Pharmaceuticals UK Limited, Horsham, West Sussex, United Kingdom

This consent is given subject to the following conditions:

Clozapine may only be prescribed by:
(a) medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branches of psychological medicine or psychiatry; and
(b) 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 Clozapine 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 use of Clozapine.

Note: This consent is valid for 2 years from 4 February 2001.

Product:
Clozaril

Active Ingredient(s):
Clozapine 25mg

Dosage Form:
Tablet

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer(s):
Novartis Pharmaceuticals UK Limited, Horsham, West Sussex, United Kingdom

This consent is given subject to the following conditions:

Clozapine may only be prescribed by:
(a) medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branches of psychological medicine or psychiatry; and
(b) 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 Clozapine 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 use of Clozapine.

Note: This consent is valid for 2 years from 4 February 2001.

Dated this 11th day of April 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).

go2752

VUW Te Waharoa — NZ Gazette 2001, No 41

Gazette.govt.nz — NZ Gazette 2001, No 41

Parliament House (depicted) was completed in 1918 and remains the primary seat of Parliament.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

Domain🏥 Health & Social Welfare
Dated11 April 2001
KeywordsMedicines, Consent, Distribution, Infanrix-penta, Miacalcic
👩‍💼 Officials

G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Renewal of Provisional Consent to the Distribution of a New Medicine

Domain🏥 Health & Social Welfare
Dated11 April 2001
KeywordsMedicines, Consent, Distribution, Clozaril
👩‍💼 Officials

G. R. Boyd, Chief Advisor, Safety and Regulation

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