New Zealand Gazette – 2009 – No. 20

Page 469

✨ Medicines Distribution Consent

19 FEBRUARY 2009 NEW ZEALAND GAZETTE, No. 20 469

Product: Xigris
Active Ingredient: Drotrecogin alfa (activated) 5mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: DSM Pharmaceuticals Inc, Greenville, North Carolina, United States of America

Dated this 12th day of February 2009.

STEWART JESSAMINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 18mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America

Product: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 27mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America

Product: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 36mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America

Product: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 54mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America

Dated this 12th day of February 2009.

STEWART JESSAMINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (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 Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to imatinib base 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This renewed consent is valid for two years from 14 April 2009.

Product: Glivec
Active Ingredient: Imatinib mesilate 478mg equivalent to imatinib base 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This renewed consent is valid for two years from 14 April 2009.

Dated this 12th day of February 2009.

STEWART JESSAMINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Gazette.govt.nz — NZ Gazette 2009, No 20

The Executive Wing of Parliament (depicted) is universally known as The Beehive. It was completed in 1977 and remains the primary office for the elected Government of the day.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

Domain🏥 Health & Social Welfare
Dated12 February 2009
KeywordsMedicines Act 1981, New Medicines, Distribution Consent, Xigris
👩‍💼 Officials

STEWART JESSAMINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Consent to the Distribution of a Changed Medicine

Domain🏥 Health & Social Welfare
Dated12 February 2009
KeywordsMedicines Act 1981, Changed Medicine, Distribution Consent, Concerta Extended Release Tablets
👩‍💼 Officials

STEWART JESSAMINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Renewal of Provisional Consent to the Distribution of a Medicine

Domain🏥 Health & Social Welfare
Dated12 February 2009
KeywordsMedicines Act 1981, Provisional Consent, Renewal, Glivec
👩‍💼 Officials

STEWART JESSAMINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

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NZ Gazette Sources

The primary sources for the issues of the NZ Gazette indexed by this project are:

New Zealand Gazette Archive, provided by Victoria University Library, copyright 2008 LexisNexis NZ Limited, Crown Copyright of New Zealand Gazette Office
- Issues from 1841-2008, including the New Munster, New Ulster, and Provincial Gazettes
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- Issues from 1913-1999
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Additional Sources

Wellington City Recollect have made available a comprehensive and excellent-quality scan of the Wellington Provincial Gazette which was used to fill in a number of issues missing from Victoria University's Gazette Archive; in particular, all 1856 issues, issues 22-34 for 1864 and issues 9-19 for 1870.
27 issues of The New Zealand Advertiser and Bay of Islands Gazette (1840) were sourced from Papers Past (public domain).
Gazette Extraordinary No. 1 (1840), held at the Alexander Turnbull Library, Wellington, New Zealand. Imaged by Luke Howison at the National Library reading rooms; PDF released into the public domain.

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The logo in the header is an edited version of “Winning Coat of Arms Competition Entry, 1908” by Archives New Zealand, CC BY 2.0 (found via Wikipedia).

Who made this?

I'm Luke Howison, a freelance web developer with an interest in genealogy. I have created several websites for genealogical research, such as NZ Ancestor Search Helper.

New Zealand Gazette Index

New Zealand Gazette – 2009 – No. 20

Page 469

Consent to the Distribution of a Changed Medicine

Renewal of Provisional Consent to the Distribution of a Medicine

Online Sources for this page:

Gazette.govt.nz — NZ Gazette 2009, No 20

✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Consent to the Distribution of a Changed Medicine

🏥 Renewal of Provisional Consent to the Distribution of a Medicine

Third-Party Content

NZ Gazette Sources

Additional Sources

PDF Icon

Masthead