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:

Delmosart
Methylphenidate hydrochloride 18mg
Modified release tablet
Teva Pharma (New Zealand) Limited
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Delmosart
Methylphenidate hydrochloride 27mg
Modified release tablet
Teva Pharma (New Zealand) Limited
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Delmosart
Methylphenidate hydrochloride 36mg
Modified release tablet
Teva Pharma (New Zealand) Limited
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Delmosart
Methylphenidate hydrochloride 54mg
Modified release tablet
Teva Pharma (New Zealand) Limited
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

DuoResp Spiromax
Budesonide 160mcg equivalent to 200mcg metered dose
Formoterol fumarate dihydrate 4.5mcg equivalent to 6mcg metered dose
Powder for inhalation
Teva Pharma (New Zealand) Limited
Norton (Waterford) Limited T/A Ivax Pharmaceuticals Ireland T/A Teva Pharmaceuticals Ireland, Waterford, Ireland
Teva Pharmaceutical Industries Limited, Jerusalem, Israel

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

DuoResp Spiromax
Budesonide 320mcg equivalent to 400mcg metered dose
Formoterol fumarate dihydrate 9mcg equivalent to 12mcg metered dose
Powder for inhalation
Teva Pharma (New Zealand) Limited
Norton (Waterford) Limited T/A Ivax Pharmaceuticals Ireland T/A Teva Pharmaceuticals Ireland, Waterford, Ireland
Teva Pharmaceutical Industries Limited, Jerusalem, Israel

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

Methylphenidate Extended Release
Methylphenidate hydrochloride 18mg
Modified release tablet
Teva Pharma (New Zealand) Limited
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Methylphenidate Extended Release
Methylphenidate hydrochloride 27mg
Modified release tablet
Teva Pharma (New Zealand) Limited
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Methylphenidate Extended Release
Methylphenidate hydrochloride 36mg
Modified release tablet
Teva Pharma (New Zealand) Limited
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Methylphenidate Extended Release
Methylphenidate hydrochloride 54mg
Modified release tablet
Teva Pharma (New Zealand) Limited
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Viberzi
Eluxadoline 75mg
Film coated tablet
Allergan New Zealand Limited
Patheon Pharmaceuticals Inc, Ohio, United States of America

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

Viberzi
Eluxadoline 100mg
Film coated tablet
Allergan New Zealand Limited
Patheon Pharmaceuticals Inc, Ohio, United States of America

Dated this 29th day of May 2019.

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