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:

Gees Linctus
Opium tincture 1.369%w/w
Squill oxymel 3.78%w/w
Linctus
PSM Healthcare Limited trading as API Consumer Brands
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

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

Nicabate Clear
Nicotine 114mg equivalent to 21mg delivered in 24 hours
Transdermal patch
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Dungarvan Limited, County Waterford, Ireland

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

Nicabate Clear
Nicotine 78mg equivalent to 14mg delivered in 24 hours
Transdermal patch
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Dungarvan Limited, County Waterford, Ireland

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

Nicabate Clear
Nicotine 36mg equivalent to 7mg delivered in 24 hours
Transdermal patch
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Dungarvan Limited, County Waterford, Ireland

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

Paracetamol Children 6–12 years
Paracetamol 5%w/v
Oral suspension
Multichem NZ Limited
Meditab Specialities Pvt Limited, Maharashtra, India

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

Risperidone Mylan
Risperidone 0.5mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

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

Risperidone Mylan
Risperidone 1mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

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

Risperidone Mylan
Risperidone 2mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

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

Risperidone Mylan
Risperidone 3mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

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

Risperidone Mylan
Risperidone 4mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

Dated this 5th day of February 2015.

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