Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 84 — 22 SEPTEMBER 2016

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Octaplas (Blood Group A)
Plasma protein fraction 9–14g
Solution for injection
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Octaplas (Blood Group B)
Plasma protein fraction 9–14g
Solution for injection
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Octaplas (Blood Group AB)
Plasma protein fraction 9–14g
Solution for injection
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Octaplas (Blood Group O)
Plasma protein fraction 9–14g
Solution for injection
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

Product:
Active Ingredients:
Factor II 220IU
Factor IX 500IU
Factor VII 180IU
Factor X 360IU
Plasma protein fraction 260mg
Protein C 140IU
Protein S precursor 140IU

Dosage Form:
Powder for injection with diluent
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturers:
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France

Pronativ

Product:
Active Ingredients:
Anti-D [Rho] immunoglobulin 625IU/mL
Plasma protein fraction 165mg/mL

Dosage Form:
Solution for injection
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturers:
Octapharma AB, Stockholm, Sweden

Rhesonativ

Product:
Active Ingredients:
Anti-D [Rho] immunoglobulin 1250IU/2mL
Plasma protein fraction 165mg/mL

Dosage Form:
Solution for injection
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturers:
Octapharma AB, Stockholm, Sweden

Product:
Active Ingredients:
Factor VIII, human 450IU
Plasma protein fraction 0–7.5mg
von Willebrand’s factor: Ristocetin cofactor 400IU

Dosage Form:
Powder for injection
New Zealand Sponsor:
Octapharma New Zealand Limited
Manufacturers:
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria

Wilate

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Online Sources for this page:

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





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
16 September 2016
Medicines Act 1981, New Medicines, Distribution, Health, Medsafe, Octaplas, Pronativ, Rhesonativ, Wilate