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:*	Alprolix
Active Ingredient:	Eftrenonacog alfa 250IU
Dosage Form:	Powder for infusion with diluent
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

*Product:*	Alprolix
Active Ingredient:	Eftrenonacog alfa 500IU
Dosage Form:	Powder for infusion with diluent
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

*Product:*	Alprolix
Active Ingredient:	Eftrenonacog alfa 1000IU
Dosage Form:	Powder for infusion with diluent
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

*Product:*	Alprolix
Active Ingredient:	Eftrenonacog alfa 2000IU
Dosage Form:	Powder for infusion with diluent
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

*Product:*	Alprolix
Active Ingredient:	Eftrenonacog alfa 3000IU
Dosage Form:	Powder for infusion with diluent
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

*Product:*	Alprolix
Active Ingredient:	Eftrenonacog alfa 4000IU
Dosage Form:	Powder for infusion with diluent
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

*Product:*	NITYR
Active Ingredient:	Nitisinone 2mg
Dosage Form:	Tablet
New Zealand Sponsor:	Orpharma NZ Limited
Manufacturers:	Penn Pharmaceutical Services Limited, Tredegar, United Kingdom Rivopharm SA, Manno, Switzerland

*Product:*	NITYR
Active Ingredient:	Nitisinone 5mg
Dosage Form:	Tablet
New Zealand Sponsor:	Orpharma NZ Limited
Manufacturers:	Penn Pharmaceutical Services Limited, Tredegar, United Kingdom Rivopharm SA, Manno, Switzerland

*Product:*	NITYR
Active Ingredient:	Nitisinone 10mg
Dosage Form:	Tablet
New Zealand Sponsor:	Orpharma NZ Limited
Manufacturers:	Penn Pharmaceutical Services Limited, Tredegar, United Kingdom Rivopharm SA, Manno, Switzerland

Dated this 18th day of September 2023.

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

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