✨ Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 103

28 AUGUST 2014

2863

Renewal of Provisional Consent to the Distribution of Medicines

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 medicines set out in the Schedule hereto:

Schedule

Product: Noradrenaline Tartrate
Active Ingredient: Noradrenaline acid tartrate monohydrate 0.12g/L equivalent to Noradrenaline base 0.06g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 2 December 2014.

Product: Noradrenaline Tartrate
Active Ingredient: Noradrenaline acid tartrate monohydrate 0.199g/L equivalent to Noradrenaline base 0.1g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 2 December 2014.

Product: Noradrenaline Tartrate
Active Ingredient: Noradrenaline acid tartrate monohydrate 0.239g/L equivalent to Noradrenaline base 0.12g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 2 December 2014.

Product: Noradrenaline Tartrate
Active Ingredient: Noradrenaline acid tartrate monohydrate 0.319g/L equivalent to Noradrenaline base 0.16g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 2 December 2014.

Dated this 22nd day of August 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new 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: Humira
Active Ingredient: Adalimumab 20mg/0.4mL
Dosage Form: Solution for injection
New Zealand Sponsor: AbbVie Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product: Humira
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AbbVie Limited
Manufacturers:
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Product: Humira Pen
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AbbVie Limited
Manufacturers:
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
Aesica Queenborough Limited, Kent, United Kingdom



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 103





✨ LLM interpretation of page content

πŸ₯ Renewal of Provisional Consent to the Distribution of Medicines

πŸ₯ Health & Social Welfare
22 August 2014
Medicines, Distribution, Renewal, Noradrenaline Tartrate, Biomed Limited
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution, Consent, Humira, AbbVie Limited