A corrigendum to this notice was published on 10 July 2018, Notice No. 2018-go3405.

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 set out in the Schedule hereto:

Schedule

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

Afstyla
Lonoctocog alfa 250IU
Powder for injection with diluent
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany

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

Afstyla
Lonoctocog alfa 500IU
Powder for injection with diluent
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany

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

Afstyla
Lonoctocog alfa 1000IU
Powder for injection with diluent
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany

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

Afstyla
Lonoctocog alfa 1500IU
Powder for injection with diluent
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany

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

Afstyla
Lonoctocog alfa 2000IU
Powder for injection with diluent
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany

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

Afstyla
Lonoctocog alfa 2500IU
Powder for injection with diluent
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany

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

Afstyla
Lonoctocog alfa 3000IU
Powder for injection with diluent
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany

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

Baclofen Injection
Baclofen 0.05mg/mL
Solution for injection
Medicianz Healthcare Limited, distributed by Medsurge Healthcare Limited
Bioindustria Laboratorio Italiano Medicinali SpA, Novi Ligure, Italy

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

Baclofen Injection
Baclofen 0.5mg/mL
Solution for injection
Medicianz Healthcare Limited, distributed by Medsurge Healthcare Limited
Bioindustria Laboratorio Italiano Medicinali SpA, Novi Ligure, Italy

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

Baclofen Injection
Baclofen 2mg/mL
Solution for injection
Medicianz Healthcare Limited, distributed by Medsurge Healthcare Limited
Bioindustria Laboratorio Italiano Medicinali SpA, Novi Ligure, Italy

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

Mupirocin Ointment
Mupirocin 20mg/g
Topical ointment
Medicianz Healthcare Limited, distributed by Medsurge Healthcare Limited
Bioindustria Laboratorio Italiano Medicinali SpA, Novi Ligure, Italy

Dated this 25th day of June 2018.

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