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:

Arostea
Etoricoxib 30mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, India

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

Arostea
Etoricoxib 60mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, India

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

Arostea
Etoricoxib 90mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, India

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

Arostea
Etoricoxib 120mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, India

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

Atomoxetine
Atomoxetine hydrochloride 5.715mg equivalent to atomoxetine 5mg
Capsule
Generic Partners (NZ) Limited
Pharmaceutical Works Polpharma SA, Gdanski, Poland

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

Atomoxetine
Atomoxetine hydrochloride 11.43mg equivalent to atomoxetine 10mg
Capsule
Generic Partners (NZ) Limited
Pharmaceutical Works Polpharma SA, Gdanski, Poland

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

Atomoxetine
Atomoxetine hydrochloride 20.574mg equivalent to atomoxetine 18mg
Capsule
Generic Partners (NZ) Limited
Pharmaceutical Works Polpharma SA, Gdanski, Poland

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

Atomoxetine
Atomoxetine hydrochloride 28.575mg equivalent to atomoxetine 25mg
Capsule
Generic Partners (NZ) Limited
Pharmaceutical Works Polpharma SA, Gdanski, Poland

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

Atomoxetine
Atomoxetine hydrochloride 45.72mg equivalent to atomoxetine 40mg
Capsule
Generic Partners (NZ) Limited
Pharmaceutical Works Polpharma SA, Gdanski, Poland

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

Atomoxetine
Atomoxetine hydrochloride 68.58mg equivalent to atomoxetine 60mg
Capsule
Generic Partners (NZ) Limited
Pharmaceutical Works Polpharma SA, Gdanski, Poland

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

Atomoxetine
Atomoxetine hydrochloride 91.44mg equivalent to atomoxetine 80mg
Capsule
Generic Partners (NZ) Limited
Pharmaceutical Works Polpharma SA, Gdanski, Poland

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

Atomoxetine
Atomoxetine hydrochloride 114.3mg equivalent to atomoxetine 100mg
Capsule
Generic Partners (NZ) Limited
Pharmaceutical Works Polpharma SA, Gdanski, Poland

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Emtricitabine/Tenofovir disoproxil
Emtricitabine 200mg
Tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg
Film coated tablet
Teva Pharma (New Zealand) Limited
Remedica Limited, Limassol, Cyprus

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

Fexofenadine
Fexofenadine hydrochloride 120mg
Film coated tablet
REX Medical Limited
Cipla Limited, Maharashtra, India

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

Fexofenadine
Fexofenadine hydrochloride 180mg
Film coated tablet
REX Medical Limited
Cipla Limited, Maharashtra, India

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

Tenofovir disoproxil tablets
Tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg
Film coated tablet
Teva Pharma (New Zealand) Limited
Remedica Limited, Limassol, Cyprus

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

Xiaflex
Collagenase clostridium histolyticum 900mcg
Powder for injection with diluent
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Jubilant HollisterStier LLC, Washington, United States of America


Dated this 17th day of November 2017.

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