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: Aspirin
Active Ingredient: Aspirin 100mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Medreich Limited, Bangalore, India
   
Product: Hyrimoz
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Bangalore, India
   
Product: Hyrimoz (Pen)
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Bangalore, India
   
Product: Octreotide Depot
Active Ingredient: Octreotide acetate 11.2mg equivalent to octreotide 10mg
Dosage Form: Powder for injection
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Pharmathen International SA, Rodopi, Greece
   
Product: Octreotide Depot
Active Ingredient: Octreotide acetate 22.4mg equivalent to octreotide 20mg
Dosage Form: Powder for injection
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Pharmathen International SA, Rodopi, Greece
   
Product: Octreotide Depot
Active Ingredient: Octreotide acetate 33.6mg equivalent to octreotide 30mg
Dosage Form: Powder for injection
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Pharmathen International SA, Rodopi, Greece


Dated this 14th 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).