4500 NEW ZEALAND GAZETTE, No. 177 20 OCTOBER 2005

Note: This consent is valid for two years from the date of publication of this notice.
Dated this 12th day of October 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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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: Fabrazyme
Active Ingredient: Agalsidase beta - rch 5.5mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited (trading as Healthcare Logistics)
Manufacturer: Genzyme Corporation, Allston, Massachusetts, United States of America

Note: This consent is valid for two years from the date of publication of this notice.
Dated this 12th day of October 2005.
DON MATHESON, Deputy 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: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to 100mg imatinib base
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Note: This consent is valid for two years from 18 October 2005.

Product: Glivec
Active Ingredient: Imatinib mesilate 59.75mg equivalent to 50mg imatinib base
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Note: This consent is valid for two years from 18 October 2005.
Dated this 12th day of October 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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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

Product: Gemzar
Active Ingredient: Gemcitabine hydrochloride 1,140mg equivalent to 1000mg Gemcitabine free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Lilly France S.A.S., Fegersheim, France
Lilly Technology Center, Indianapolis, Indiana, United States of America
VIANEX S.A., Plant C, Pallini Attikis, Greece

Product: Gemzar
Active Ingredient: Gemcitabine hydrochloride 228mg equivalent to 200mg Gemcitabine free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Lilly France S.A.S., Fegersheim, France
Lilly Technology Center, Indianapolis, Indiana, United States of America