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 Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Apo-Candesartan HCTZ 16/12.5
Candesartan cilexetil 16mg
Hydrochlorothiazide 12.5mg
Tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Apo-Candesartan HCTZ 32/12.5
Candesartan cilexetil 32mg
Hydrochlorothiazide 12.5mg
Tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Apo-Candesartan HCTZ 32/25
Candesartan cilexetil 32mg
Hydrochlorothiazide 25mg
Tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

Finasteride
Finasteride 1mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Labs Limited, Hyderabad, India

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

Finasteride
Finasteride 5mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Labs Limited, Hyderabad, India

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

Noradrenaline BNM
Noradrenaline acid tartrate 2mg/mL equivalent to 1mg/mL noradrenaline base
Concentrate for injection
Boucher & Muir (New Zealand) Limited trading as BNM Group
Sintetica SA, Mendrisio, Switzerland

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

Robitussin Dry Cough Liquid Capsules
Dextromethorphan hydrobromide monohydrate 15mg
Liquid filled capsule
Pfizer New Zealand Limited
Catalent Pharma Solutions LLC, Florida, United States of America

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Zepatier
Elbasvir 50mg
Grazoprevir 100mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
MSD International GmbH (Ireland), Clonmel, Ireland

Dated this 28th day of November 2016.

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