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:
Manufacturer:

Hizentra
Normal immunoglobulin 200mg/mL
Solution for injection
CSL Behring (NZ) Limited
CSL Behring AG, Bern, Switzerland

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

Remifentanil-AFT
Remifentanil hydrochloride 1.097mg equivalent to Remifentanil 1mg
Powder for injection
AFT Pharmaceuticals Limited
Laboratorio Reig Jofre SA, Barcelona, Spain

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

Remifentanil-AFT
Remifentanil hydrochloride 2.194mg equivalent to Remifentanil 2mg
Powder for injection
AFT Pharmaceuticals Limited
Laboratorio Reig Jofre SA, Barcelona, Spain

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

Remifentanil-AFT
Remifentanil hydrochloride 5.485mg equivalent to Remifentanil 5mg
Powder for injection
AFT Pharmaceuticals Limited
Laboratorio Reig Jofre SA, Barcelona, Spain

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

Serophene
Clomifene citrate 50mg
Tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Teva Pharmaceutical Industries Limited, Kfar Saba, Israel

Dated this 4th day of December 2015.

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