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:*	Beriplex NZ
Active Ingredients:	Factor II 400IU Factor IX 400IU Factor VII 200IU Factor X 440IU Protein C 300IU Protein S precursor 240IU Prothrombin complex concentrates 120mg
Dosage Form:	Powder for injection with diluent
New Zealand Sponsor:	CSL Behring (NZ) Limited
Manufacturer:	CSL Behring GmbH, Marburg, Germany

*Product:*	Testosterone undecanoate
Active Ingredient:	Testosterone undecylate 250mg/mL equivalent to testosterone 157.9mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	Laboratorios Farmalan S.A., Leon, Spain

Dated this 15th day of November 2024.

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

Tags

Notice Number

Schedule