β¨ Medicines Distribution Consents
NEW ZEALAND GAZETTE, No. 63 β 14 JULY 2016
| Type | Name | Requirements |
|---|---|---|
| 1 | ||
| National Institute of Water and Atmospheric Research Limited | R | |
| New Zealand Forest Research Institute Limited | R | |
| New Zealand Institute for Plant and Food Research Limited | R |
2016-go3995
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:
Fenpaed Double Strength
Active Ingredient:
Ibuprofen 40mg/mL
Dosage Form:
Oral suspension
New Zealand Sponsor:
AFT Pharmaceuticals Limited
Manufacturer:
Pinewood Laboratories Limited, Clonmel, Ireland
Dated this 7th day of July 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2016-go4006
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:
Neulastim
Active Ingredient:
Pegfilgrastim 10mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Amgen New Zealand Limited
Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Amgen Manufacturing Limited, Juncos, Puerto Rico
Product:
Neupogen
Active Ingredient:
Filgrastim 300mcg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Amgen New Zealand Limited
Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Amgen Manufacturing Limited, Juncos, Puerto Rico
Product:
Neupogen
Active Ingredient:
Filgrastim 600mcg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Amgen New Zealand Limited
Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Amgen Manufacturing Limited, Juncos, Puerto Rico
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NZ Business Number Compliance Requirements for Crown Entities
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ποΈ Governance & Central AdministrationNZBN, Compliance, Crown Entities, Tier One, Tier Two, Tier Three, Tier Four, Requirements
π₯ Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare7 July 2016
Medicine, Distribution, Ibuprofen, Oral suspension, AFT Pharmaceuticals
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines, Distribution, Pegfilgrastim, Filgrastim, Amgen New Zealand
NZ Gazette 2016, No 63