✨ Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 132 β€” 3 DECEMBER 2015

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:
Xyntha
Active Ingredient:
Moroctocog alfa 250IU equivalent to 23mcg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturers:
Wyeth Farma SA, Madrid, Spain
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Xyntha
Active Ingredient:
Moroctocog alfa 500IU equivalent to 45mcg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturers:
Wyeth Farma SA, Madrid, Spain
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Xyntha
Active Ingredient:
Moroctocog alfa 1000IU equivalent to 90mcg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturers:
Wyeth Farma SA, Madrid, Spain
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Xyntha
Active Ingredient:
Moroctocog alfa 2000IU equivalent to 180mcg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturers:
Wyeth Farma SA, Madrid, Spain
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Xyntha
Active Ingredient:
Moroctocog alfa 3000IU
Dosage Form:
Powder for injection
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturer:
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Dated this 26th day of November 2015.

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


2015-go7017

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:
Apo-Riluzole
Active Ingredient:
Riluzole 50mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Apotex NZ Limited
Manufacturer:
Apotex Research Private Limited, Bangalore, India

Note: This consent is given subject to the following condition: Apo-Riluzole 50mg tablets can only be prescribed by specialist physicians who care for patients with motor neuron diseases, neurologists and palliative care physicians.

Also Note: This consent is valid for two years from the date of publication of this notice.

Dated this 26th day of November 2015.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister

of Health on 11 September 2013).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2015, No 132





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
26 November 2015
Medicines, Xyntha, Moroctocog alfa, Pfizer, Medicines Act 1981
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

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

πŸ₯ Health & Social Welfare
26 November 2015
Medicines, Apo-Riluzole, Riluzole, Apotex, Medicines Act 1981
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health