✨ Medicines Distribution Consents




722 NEW ZEALAND GAZETTE, No. 27 23 MARCH 2006

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 changed 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: Herceptin
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche AG, Basel, Switzerland

Product: Herceptin
Active Ingredient: Trastuzumab 440mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche AG, Basel, Switzerland
Genentech Inc, South San Francisco, California, United States of America

Dated this 16th day of March 2006.

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 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 changed 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: Humira
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany

Change of indication

Product: Humira
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany

Change of indication

Dated this 18th day of March 2006.

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: Gutron
Active Ingredient: Midodrine hydrochloride 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Nycomed Austria GmbH, Linz, Austria
Note: This consent is valid for two years from 30 April 2006.

Product: Gutron
Active Ingredient: Midodrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Nycomed Austria GmbH, Linz, Austria
Note: This consent is valid for two years from 30 April 2006.



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2006, No 27


Gazette.govt.nz PDF NZ Gazette 2006, No 27





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a Changed Medicine - Herceptin

πŸ₯ Health & Social Welfare
16 March 2006
Medicines Act 1981, Herceptin, Trastuzumab, Roche Products (New Zealand) Limited
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Consent to the Distribution of a Changed Medicine - Humira

πŸ₯ Health & Social Welfare
18 March 2006
Medicines Act 1981, Humira, Adalimumab, Abbott Laboratories (NZ) Limited
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine - Gutron

πŸ₯ Health & Social Welfare
Medicines Act 1981, Gutron, Midodrine hydrochloride, Douglas Pharmaceuticals Limited