✨ Medicine Distribution Consents




24 SEPTEMBER 2009 NEW ZEALAND GAZETTE, No. 140 3329

Product:
Vimpat
Active Ingredient:
Lacosamide 15mg/mL
Dosage Form:
Oral solution
New Zealand Sponsor:
Pharmabroker Sales Limited
Manufacturer:
Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America

Product:
Vimpat
Active Ingredient:
Lacosamide 10mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Pharmabroker Sales Limited
Manufacturer:
EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria

Dated this 17th day of September 2009.

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

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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

Product:
Diclohexal
Active Ingredient:
Diclofenac sodium 25mg
Dosage Form:
Enteric coated tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturers:
Salutas Pharma GmbH, Barleben, Germany
Sandoz do Brasil Industria Farmaceutica Ltda, Parana, Brazil

Product:
Diclohexal
Active Ingredient:
Diclofenac sodium 50mg
Dosage Form:
Enteric coated tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturers:
Salutas Pharma GmbH, Barleben, Germany
Sandoz do Brasil Industria Farmaceutica Ltda, Parana, Brazil

Dated this 22nd day of September 2009.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of 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(1) 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:
GenRx Moclobemide
Active Ingredient:
Moclobemide 300mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Apotex NZ Limited
Manufacturer:
Apotex Inc, Ontario, Canada

Product:
GenRx-Moclobemide
Active Ingredient:
Moclobemide 150mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Apotex NZ Limited
Manufacturer:
Apotex Inc, Ontario, Canada

Note: This consent is valid for 12 months from the date of publication of this notice and is subject to the following condition:

  • Apotex NZ Limited provides additional data within nine months from the date of publication of this notice to satisfy me that the packaged product remains efficacious for its stated shelf life.

Dated this 22nd day of September 2009.

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

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2009, No 140





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicine (Vimpat) (continued from previous page)

πŸ₯ Health & Social Welfare
17 September 2009
Medicine distribution, Vimpat, Lacosamide, Oral solution, Injection solution
  • STUART POWELL, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

πŸ₯ Consent to the Distribution of a New Medicine (Diclohexal)

πŸ₯ Health & Social Welfare
22 September 2009
Medicine distribution, Diclohexal, Diclofenac sodium, Enteric coated tablet
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of a New Medicine (GenRx Moclobemide)

πŸ₯ Health & Social Welfare
22 September 2009
Medicine distribution, Provisional consent, GenRx Moclobemide, Moclobemide, Film coated tablet
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health