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:

Midazolam-Claris
Midazolam 1mg/mL
Solution for injection
AFT Pharmaceuticals Limited
Claris Injectables Limited, Ahmedabad, India

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

Midazolam-Claris
Midazolam 5mg/mL
Solution for injection
AFT Pharmaceuticals Limited
Claris Injectables Limited, Ahmedabad, India

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

Ofev
Nintedanib esilate 120.4mg equivalent to nintedanib 100mg
Liquid filled capsule
Boehringer Ingelheim (NZ) Limited
Catalent Germany Eberbach GmbH, Baden, Germany

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

Ofev
Nintedanib esilate 180.6mg equivalent to nintedanib 150mg
Liquid filled capsule
Boehringer Ingelheim (NZ) Limited
Catalent Germany Eberbach GmbH, Baden, Germany

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

Uptravi
Selexipag 200mcg
Film coated tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Excella GmbH, Feucht, Germany

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

Uptravi
Selexipag 400mcg
Film coated tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Excella GmbH, Feucht, Germany

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

Uptravi
Selexipag 600mcg
Film coated tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Excella GmbH, Feucht, Germany

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

Uptravi
Selexipag 800mcg
Film coated tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Excella GmbH, Feucht, Germany

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

Uptravi
Selexipag 1000mcg
Film coated tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Excella GmbH, Feucht, Germany

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

Uptravi
Selexipag 1200mcg
Film coated tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Excella GmbH, Feucht, Germany

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

Uptravi
Selexipag 1400mcg
Film coated tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Excella GmbH, Feucht, Germany

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

Uptravi
Selexipag 1600mcg
Film coated tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Excella GmbH, Feucht, Germany

Dated this 10th day of March 2016.

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