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: Brintellix
Active Ingredient: Vortioxetine hydrobromide 6.355mg equivalent to vortioxetine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Copenhagen, Denmark
   
Product: Brintellix
Active Ingredient: Vortioxetine hydrobromide 12.71mg equivalent to vortioxetine 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Copenhagen, Denmark
   
Product: Brintellix
Active Ingredient: Vortioxetine hydrobromide 19.065mg equivalent to vortioxetine 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Copenhagen, Denmark
   
Product: Brintellix
Active Ingredient: Vortioxetine hydrobromide 25.42mg equivalent to vortioxetine 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Copenhagen, Denmark
   
Product: Tacrolimus Mylan
Active Ingredient: Tacrolimus monohydrate 0.5mg equivalent to tacrolimus 0.5mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Intas Pharmaceuticals Limited, Sanand, India
   
Product: Tacrolimus Mylan
Active Ingredient: Tacrolimus monohydrate 1mg equivalent to tacrolimus 1mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Intas Pharmaceuticals Limited, Sanand, India
   
Product: Tacrolimus Mylan
Active Ingredient: Tacrolimus monohydrate 5mg equivalent to tacrolimus 5mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Intas Pharmaceuticals Limited, Sanand, India


Dated this 28th 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).