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:

Esbriet
Pirfenidone 267mg
Film coated tablet
Roche Products (NZ) Limited
Roche SpA, Milan, Italy

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

Esbriet
Pirfenidone 534mg
Film coated tablet
Roche Products (NZ) Limited
Roche SpA, Milan, Italy

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

Esbriet
Pirfenidone 801mg
Film coated tablet
Roche Products (NZ) Limited
Roche SpA, Milan, Italy

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

Keytruda
Pembrolizumab 25mg/mL
Concentrate for infusion
Merck Sharp & Dohme (New Zealand) Limited
MSD International GmbH (Ireland), Carlow, Ireland

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

Phosphate Phebra
Monobasic sodium phosphate 1.936g equivalent to phosphorus 500mg
Effervescent tablet
KSJ Pharmatech Limited
Alpex Pharma SA, Mezzovico, Switzerland

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

Venlafaxine Mylan
Venlafaxine hydrochloride 42.42mg equivalent to venlafaxine 37.5mg
Modified release capsule
Mylan New Zealand Limited
Mylan Laboratories Limited, Sinnar, India

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

Venlafaxine Mylan
Venlafaxine hydrochloride 84.85mg equivalent to venlafaxine 75mg
Modified release capsule
Mylan New Zealand Limited
Mylan Laboratories Limited, Sinnar, India

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

Venlafaxine Mylan
Venlafaxine hydrochloride 169.7mg equivalent to venlafaxine 150mg
Modified release capsule
Mylan New Zealand Limited
Mylan Laboratories Limited, Sinnar, India

Dated this 23rd day of March 2018.

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