✨ Medicines Distribution Consents




366 NEW ZEALAND GAZETTE No. 16

Schedule

Name and Strength Form Name and Address of Manufacturer Proprietary Name (if any)
Sodium monofluorophosphate Toothpaste Colgate-Palmolive Pty Limited, Labrador, Queensland, Australia Colgate Sensation Whitening Fluoride Toothpaste plus Tartar
0.75% w/w
Sodium fluoride 0.22% w/w Toothpaste Laboratorios Boniquet SA., Poligono Industrial Santiga, Barcelona, Spain Yotuel

Dated this 26th day of January 1999.

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

Name and Strength Form Name and Address of Manufacturer Proprietary Name (if any)
Quinapril hydrochloride Tablets Godecke AG, Freiburg, Germany and Parke Davis, Orleans Cedex, France Accupril
equivalent to 5 mg, 10 mg, 20 mg quinapril
Hepatitis B virus vaccine Injection, solution SmithKline Beecham Biologicals Manufacturing, Rixensart, Belgium Engerix-B
inactivated 10Β΅g in 0.5 mL, 20Β΅g in 1 mL
Saquinavir 200 mg Capsule, soft gelatin R P Scherer GmbH., Eberbach/Baden, Germany Fortovase
Lenograstim 13.4MIU Injection, powder Chugai Pharmaceutical Co Limited, Utsunomiya, Tochigi, Japan Granocyte 13
Lenograstim 33.6MIU Injection, powder Chugai Pharmaceutical Co Limited, Utsunomiya, Tochigi, Japan Granocyte 34
Paclitaxel 6 mg/mL Infusion, concentrate Bristol-Caribbean Inc., Mayaguez, Puerto Rico Taxol

Dated this 31st day of January 1999.

G. R. BOYD, Chief Advisor, Regulation and Safety, 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, I provisionally consent to the sale, supply, or use in New Zealand of the new medicine (Clozaril) described in the Schedule hereto. This provisional consent has effect for 2 years from 4 February 1999.

This provisional consent is subject to the following conditions:

(i) 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 in paragraph (a) above.

(ii) 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.

Schedule

Name and Strength Form Name and Address of Manufacturer Proprietary Name (if any)
Clozapine 25 mg, Tablet Novartis Pharma AG., Basle, Switzerland Clozaril
100 mg

Dated at Wellington this 31st day of January 1999.

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

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✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a New Related Product

πŸ₯ Health & Social Welfare
26 January 1999
Medicines, Distribution, New Related Product, Toothpaste, Fluoride
  • G. R. Boyd, Chief Advisor, Regulation and Safety

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
31 January 1999
Medicines, Distribution, Changed Medicines, Tablets, Injection, Capsule, Infusion
  • G. R. Boyd, Chief Advisor, Regulation and Safety

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

πŸ₯ Health & Social Welfare
31 January 1999
Medicines, Provisional Consent, Renewal, Clozapine, Tablet
  • G. R. Boyd, Chief Advisor, Regulation and Safety