New Zealand Gazette – 1997 – No. 178

Page 4261

✨ Medicines Act Notices

NEW ZEALAND GAZETTE

18 DECEMBER

Medicines Act 1981

Corrigendum

In the notice published in the New Zealand Gazette, 30 October 1997, No. 155, page 3661, notice No. 7773, replace the entry with the following (the difference between this notice and the previous notice is the inclusion of the prescribing information):

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

Name and Strength	Form	Name and Address of Manufacturer	Proprietary Name (if any)
Warfarin sodium 1 mg, 2 mg, 5 mg	Tablets	The Boots Company PLC., Nottingham, United Kingdom	Coumadin

Note: This consent is valid for 2 years from 31 October 1997.

This medicine may only be distributed, supplied or used under the following conditions:

The product is not to be marketed as substitutable for Marevan as if the two (2) products were bioequivalent; and
Prescribers are to be advised that when starting on Coumadin the dosage for each patient should be individually titrated according to therapeutic response determined by monitoring appropriate coagulation parameter.

Dated this 15th day of December 1997.

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)
Disodium clodronate 520 mg	Tablet, film coated	Boehringer Mannheim GmbH., Mannheim, Germany	Ostac
Disodium clodronate 400 mg	Capsule	Boehringer Mannheim GmbH., Mannheim, Germany	Ostac

Dated this 12th day of December 1997.

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 a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Name and Strength	Form	Name and Address of Manufacturer	Proprietary Name (if any)
Tolcapone 100 mg, 200 mg	Tablet, film coated	F Hoffmann-La Roche Limited, Basle, Switzerland	Tasmar

Dated this 8th day of December 1997.

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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VUW Te Waharoa — NZ Gazette 1997, No 178

NZLII — NZ Gazette 1997, No 178

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✨ LLM interpretation of page content

🏥 Corrigendum to Renewal of Provisional Consent for Warfarin Sodium

Domain🏥 Health & Social Welfare
Dated15 December 1997
KeywordsMedicines Act 1981, Corrigendum, Warfarin sodium, Coumadin, Provisional consent
👩‍💼 Officials

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

🏥 Consent to Distribution of Changed Medicines

Domain🏥 Health & Social Welfare
Dated12 December 1997
KeywordsMedicines Act 1981, Disodium clodronate, Ostac, Changed medicines
👩‍💼 Officials

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

🏥 Consent to Distribution of New Medicine Tolcapone

Domain🏥 Health & Social Welfare
Dated8 December 1997
KeywordsMedicines Act 1981, Tolcapone, Tasmar, New medicine
👩‍💼 Officials

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

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