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:

Glycopyrronium Bromide 0.5mg/mL and
Neostigmine Metilsulfate 2.5mg/mL Injection

Glycopyrronium bromide 0.5mg/mL
Neostigmine metilsulfate 2.5mg/mL
Solution for injection
Max Health Limited
Martindale Pharmaceuticals, Essex, United Kingdom

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

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 5mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 10mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 15mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 20mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 30mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 40mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 60mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 80mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

Dated this 18th day of August 2016.

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