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Notice Type
Departmental
Notice Title

Suspension of Consent to the Distribution of Medicines

Pursuant to section 35(1)(c) of the Medicines Act 1981, the Minister of Health hereby suspends consent to the distribution in New Zealand of the following medicines for a period of one year from 12 March 2015:

Schedule

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

Pioglitazone Hydrochloride
Pioglitazone hydrochloride 16.54mg equivalent to Pioglitazone 15mg
Tablet
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

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

Pioglitazone Hydrochloride
Pioglitazone hydrochloride 33.07mg equivalent to Pioglitazone 30mg
Tablet
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

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

Pioglitazone Hydrochloride
Pioglitazone hydrochloride 49.61mg equivalent to Pioglitazone 45mg
Tablet
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Pramipexole Hydrochloride
Pramipexole hydrochloride monohydrate 0.125mg
equivalent to Pramipexole 0.088mg
Tablet
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

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

Pramipexole Hydrochloride
Pramipexole hydrochloride monohydrate 0.25mg equivalent to Pramipexole 0.18mg
Tablet
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

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

Pramipexole Hydrochloride
Pramipexole hydrochloride monohydrate 0.5mg equivalent to Pramipexole 0.35mg
Tablet
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

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

Pramipexole Hydrochloride
Pramipexole hydrochloride monohydrate 1mg equivalent to Pramipexole 0.7mg
Tablet
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

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

Ropaccord
Ropinirole hydrochloride 0.285mg equivalent to Ropinirole 0.25mg
Film coated tablet
Accord Healthcare NZ Limited
Intas Pharmaceuticals Limited, Gujarat, India

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

Ropaccord
Ropinirole hydrochloride 0.57mg equivalent to Ropinirole 0.5mg
Film coated tablet
Accord Healthcare NZ Limited
Intas Pharmaceuticals Limited, Gujarat, India

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

Ropaccord
Ropinirole hydrochloride 1.14mg equivalent to Ropinirole 1mg
Film coated tablet
Accord Healthcare NZ Limited
Intas Pharmaceuticals Limited, Gujarat, India

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

Ropaccord
Ropinirole hydrochloride 2.28mg equivalent to Ropinirole 2mg
Film coated tablet
Accord Healthcare NZ Limited
Intas Pharmaceuticals Limited, Gujarat, India

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

Ropaccord
Ropinirole hydrochloride 5.7mg equivalent to Ropinirole 5mg
Film coated tablet
Accord Healthcare NZ Limited
Intas Pharmaceuticals Limited, Gujarat, India

Dated this 5th day of March 2015.

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