✨ Consent to Distribution of New Medicines




NEW ZEALAND GAZETTE, No. 84 β€” 22 SEPTEMBER 2016

2016-go5374

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:
Elidel
Active Ingredient:
Pimecrolimus 10mg/g
Dosage Form:
Topical cream
New Zealand Sponsor:
CARSL Consulting
Manufacturers:
Novartis Pharma Produktions GmbH, Wehr, Germany
Meda Manufacturing, Merignac, France

Product:
Gammanorm
Active Ingredient:
Normal immunoglobulin 165mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturer:
Octapharma AB, Stockholm, Sweden

Product:
Octagam
Active Ingredient:
Normal immunoglobulin 50mg/mL
Dosage Form:
Solution for infusion
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturers:
Octapharma AB, Stockholm, Sweden
Octapharma, Lingolsheim, France
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

Product:
Octalbin
Active Ingredient:
Albumin 50g/L
Dosage Form:
Solution for infusion
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturer:
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

Product:
Octalbin
Active Ingredient:
Albumin 200g/L
Dosage Form:
Solution for infusion
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturer:
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

Product:
Octanate
Active Ingredient:
Factor VIII, human 250IU
Dosage Form:
Powder for injection with diluent
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturers:
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France
Octapharma AB, Stockholm, Sweden

Product:
Octanate
Active Ingredient:
Factor VIII, human 500IU
Dosage Form:
Powder for injection with diluent
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturers:
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France
Octapharma AB, Stockholm, Sweden

Product:
Octanate
Active Ingredient:
Factor VIII, human 1000IU
Dosage Form:
Powder for injection with diluent
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturers:
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France
Octapharma AB, Stockholm, Sweden

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 84





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
16 September 2016
Medicines Act 1981, New Medicines, Distribution, Health, Medsafe, Elidel, Gammanorm, Octagam, Octalbin, Octanate