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: Fasenra
Active Ingredient: Benralizumab 30mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Maryland, United States of America
Catalent Indiana LLC, Indiana, United States of America
   
Product: Oncaspar
Active Ingredient: Pegaspargase 750U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Servier Laboratories Limited
Manufacturer: Exelead Inc, Indiana, United States of America
   
Product: Paracare Paracetamol + Ibuprofen (General sale)
Active Ingredients: Ibuprofen 200mg
Paracetamol 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Medreich Limited, Bangalore, India


Dated this 10th day of February 2020.

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