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New Zealand Gazette – 1999 – No. 90

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✨ Medicines Act Notices

NEW ZEALAND GAZETTE

5 AUGUST

2145

Health

Medicines Act 1981

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: Omniscan.

Active Ingredient(s): Gadodiamide 287 mg/mL.
Calcium sodium 12 mg/mL.

Dosage Form: Solution for injection.

NZ Sponsor: Nycomed New Zealand Limited.

Manufacturer(s): Nycomed AS Production, Inc., Oslo, Norway.
Nycomed Puerto Rico Inc., Barceloneta, Puerto Rico.
Nycomed Ireland Limited, Carrigtwohill, Co. Cork, Eire.

Dated this 29th day of July 1999.

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

go5637

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: Xeloda.

Active Ingredient(s): Capecitabine 150 mg.

Dosage Form: Film coated tablet.

NZ Sponsor: Roche Products (New Zealand) Limited.

Manufacturer(s): Hoffmann-La Roche Inc., Nutley, New Jersey, United States of America.

Product: Xeloda.

Active Ingredient(s): Capecitabine 500 mg.

Dosage Form: Film coated tablet.

NZ Sponsor: Roche Products (New Zealand) Limited.

Manufacturer(s): Hoffmann-La Roche Inc., Nutley, New Jersey, United States of America.

Note: This consent is valid for 2 years from the date of publication of this notice.

Dated this 29th day of July 1999.

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

go5639

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

Product: Eryhexal.

Active Ingredient(s): Erythromycin ethylsuccinate 4.935 g.

Dosage Form: Powder for oral suspension.

NZ Sponsor: Hexal New Zealand Pty Limited.

Manufacturer(s): Allphamed PHARBIL Arzneimittel GmbH, Göttingen, Germany.

Product: Eryhexal.

Active Ingredient(s): Erythromycin ethylsuccinate 11.838 g.

Dosage Form: Powder for oral suspension.

NZ Sponsor: Hexal New Zealand Pty Limited.

Manufacturer(s): Allphamed PHARBIL Arzneimittel GmbH, Göttingen, Germany.

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VUW Te Waharoa — NZ Gazette 1999, No 90

NZLII — NZ Gazette 1999, No 90

The General Assembly Library (on the right) was completed in 1899 and survived the 1907 fire. Now the oldest remaining original Parliament building, still used as the Parliamentary Library.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of Changed Medicines

Domain🏥 Health & Social Welfare
Dated29 July 1999
KeywordsMedicines Act 1981, Consent, Changed Medicines, Omniscan, Gadodiamide
👩‍💼 Officials

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

🏥 Provisional Consent to the Distribution of a New Medicine

Domain🏥 Health & Social Welfare
Dated29 July 1999
KeywordsMedicines Act 1981, Provisional Consent, New Medicine, Xeloda, Capecitabine
👩‍💼 Officials

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

🏥 Consent to the Distribution of a New Medicine

Domain🏥 Health & Social Welfare
Dated29 July 1999
KeywordsMedicines Act 1981, Consent, New Medicine, Eryhexal, Erythromycin ethylsuccinate
👩‍💼 Officials

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

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