✨ 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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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 63





✨ LLM interpretation of page content

πŸ›οΈ NZ Business Number Compliance Requirements for Crown Entities (continued from previous page)

πŸ›οΈ Governance & Central Administration
NZBN, Compliance, Crown Entities, Tier One, Tier Two, Tier Three, Tier Four, Requirements

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
7 July 2016
Medicine, Distribution, Ibuprofen, Oral suspension, AFT Pharmaceuticals
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution, Pegfilgrastim, Filgrastim, Amgen New Zealand