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:

Amiodarone Hydrochloride (Hameln)
Amiodarone hydrochloride 50mg/mL
Concentrate for injection
Max Health Limited
HBM Pharma s.r.o, Martin, Slovakia

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

Brenzys (Pre-filled Pen)
Etanercept 50mg/mL
Solution for injection
Samsung Bioepis NZ Limited
Catalent Belgium SA,Brussels, Belgium
Patheon Italia SpA, Milan, Italy

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

Brenzys (Pre-filled Syringe)
Etanercept 50mg/mL
Solution for injection
Samsung Bioepis NZ Limited
Catalent Belgium SA, Brussels, Belgium
Patheon Italia SpA, Milan, Italy

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Dexamethasone Phosphate Panpharma (4mg/1mL)
Dexamethasone sodium phosphate 4.37mg/mL
equivalent to dexamethasone phosphate 4mg/mL
Solution for injection
Multichem NZ Limited
Rotexmedica GmbH Arzneimittelwerk, Trittau, Germany

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Dexamethasone Phosphate Panpharma (8mg/2mL)
Dexamethasone sodium phosphate 4.37mg/mL
equivalent to dexamethasone phosphate 4mg/mL
Solution for injection
Multichem NZ Limited
Rotexmedica GmbH Arzneimittelwerk, Trittau, Germany

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

Galderma Adapalene
Adapalene 0.1%w/w
Topical cream
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Laboratoires Galderma, Alby-sur-Cheran, France

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

Galderma Adapalene
Adapalene 0.1%w/w
Topical gel
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Laboratoires Galderma, Alby-sur-Cheran, France

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

Omeprazole Mylan
Omeprazole 40mg
Modified release capsule
Mylan New Zealand Limited
Laboratorios Liconsa SA, Guadalajara, Spain

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

Omeprazole Mylan
Omeprazole 20mg
Modified release capsule
Mylan New Zealand Limited
Laboratorios Liconsa SA, Guadalajara, Spain

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

Omeprazole Mylan
Omeprazole 10mg
Modified release capsule
Mylan New Zealand Limited
Laboratorios Liconsa SA, Guadalajara, Spain

Dated this 25th day of February 2019.

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