β¨ Medicines Distribution Notices
1 FEBRUARY 2007
NEW ZEALAND GAZETTE, No. 10
213
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
Product:
Prograf
Active Ingredient:
Tacrolimus 0.5mg
Dosage Form:
Capsule
New Zealand Sponsor:
Janssen-Cilag Pty Limited
Manufacturer:
Fujisawa Ireland Limited, Killorglin, Co Kerry, Ireland
Product:
Prograf
Active Ingredient:
Tacrolimus 1mg
Dosage Form:
Capsule
New Zealand Sponsor:
Janssen-Cilag Pty Limited
Manufacturer:
Fujisawa Ireland Limited, Killorglin, Co Kerry, Ireland
Product:
Prograf
Active Ingredient:
Tacrolimus 5mg
Dosage Form:
Capsule
New Zealand Sponsor:
Janssen-Cilag Pty Limited
Manufacturer:
Fujisawa Ireland Limited, Killorglin, Co Kerry, Ireland
Product:
Prograf
Active Ingredient:
Tacrolimus 5mg/mL
Dosage Form:
Concentrate for infusion
New Zealand Sponsor:
Janssen-Cilag Pty Limited
Manufacturer:
Fujisawa Ireland Limited, Killorglin, Co Kerry, Ireland
Product:
Remicade
Active Ingredient:
Infliximab 100mg
Dosage Form:
Powder for infusion concentrate
New Zealand Sponsor:
Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturers:
Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Monza, Milan, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Dated this 26th day of January 2007.
MARK JACOBS, Acting Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).
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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:
Clozaril
Active Ingredient:
Clozapine 100mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer:
Novartis Pharmaceuticals UK Limited, Horsham, West Sussex, United Kingdom
Conditions:
-
The medicine may only be prescribed by:
- medical practitioners who are vocationally registered under the Health Practitioners Competence Assurance Act 2003 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 (Third Edition January 2002), and the requirements of local hospital and health service protocols for the use of clozapine.
Note: This consent is valid for two years from 4 February 2007.
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2007, No 10
Gazette.govt.nz —
NZ Gazette 2007, No 10
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of Changed Medicines under Medicines Act 1981
(continued from previous page)
π₯ Health & Social Welfare26 January 2007
Medicines, Distribution, Prograf, Tacrolimus, Janssen-Cilag, Remicade, Infliximab, Schering-Plough
- MARK JACOBS, Acting Director-General, Public Health
π₯ Renewal of Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social WelfareMedicines, Provisional Consent, Clozaril, Clozapine, Novartis, Psychiatric Medicine