β¨ 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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β¨ LLM interpretation of page content
π₯
Consent to Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare26 November 2015
Medicines, Xyntha, Moroctocog alfa, Pfizer, Medicines Act 1981
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare26 November 2015
Medicines, Apo-Riluzole, Riluzole, Apotex, Medicines Act 1981
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
NZ Gazette 2015, No 132