Notice Type
Departmental
Notice Title

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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Elidel
Pimecrolimus 10mg/g
Topical cream
CARSL Consulting
Novartis Pharma Produktions GmbH, Wehr, Germany
Meda Manufacturing, Merignac, France

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

Gammanorm
Normal immunoglobulin 165mg/mL
Solution for injection
Octapharma New Zealand Limited
Octapharma AB, Stockholm, Sweden

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

Octagam
Normal immunoglobulin 50mg/mL
Solution for infusion
Octapharma New Zealand Limited
Octapharma AB, Stockholm, Sweden
Octapharma, Lingolsheim, France
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

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

Octalbin
Albumin 50g/L
Solution for infusion
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

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

Octalbin
Albumin 200g/L
Solution for infusion
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

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

Octanate
Factor VIII, human 250IU
Powder for injection with diluent
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France
Octapharma AB, Stockholm, Sweden

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

Octanate
Factor VIII, human 500IU
Powder for injection with diluent
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France
Octapharma AB, Stockholm, Sweden

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

Octanate
Factor VIII, human 1000IU
Powder for injection with diluent
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France
Octapharma AB, Stockholm, Sweden

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:






Dosage Form:
New Zealand Sponsor:
Manufacturers:

Pronativ
Factor II 220IU
Factor IX 500IU
Factor VII 180IU
Factor X 360IU
Plasma protein fraction 260mg
Protein C 140IU
Protein S precursor 140IU
Powder for injection with diluent
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Rhesonativ
Anti-D [Rho] immunoglobulin 625IU/mL
Plasma protein fraction 165mg/mL
Solution for injection
Octapharma New Zealand Limited
Octapharma AB, Stockholm, Sweden

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Rhesonativ
Anti-D [Rho] immunoglobulin 1250IU/2mL
Plasma protein fraction 165mg/mL
Solution for injection
Octapharma New Zealand Limited
Octapharma AB, Stockholm, Sweden

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturers:

Wilate
Factor VIII, human 450IU
Plasma protein fraction 0–7.5mg
von Willebrand’s factor: Ristocetin cofactor 400IU
Powder for injection
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturers:

Wilate
Factor VIII, human 900IU
Plasma protein fraction 0–15mg
von Willebrand’s factor: Ristocetin cofactor 800IU
Powder for injection
Octapharma New Zealand Limited
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria

Dated this 16th day of September 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).