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: Arabloc
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Arabloc
Active Ingredient: Leflunomide 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Arabloc
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Day & Night Cold & Flu + Cough
Day capsule
Active Ingredients: Dextromethorphan hydrobromide 10mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Capsule
Night capsule
Active Ingredients: Chlorpheniramine maleate 2mg
Dextromethorphan hydrobromide 10mg
Paracetamol 500mg
Dosage Form: Capsule
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer: Pfizer Australia Pty Limited, West Ryde, NSW, Australia
Product: Epirubicin Ebewe
Active Ingredient: Epirubicin hydrochloride 2mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: InterPharma Pty Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Product: Forteo
Active Ingredient: Teriparatide 250µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly France SAS, Fegersheim, France
Product: OxyNorm
Active Ingredient: Oxycodone hydrochloride 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Simco, Vale, Guernsey, Channel Islands
Product: Rubifen
Active Ingredient: Methylphenidate hydrochloride 20mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Laboratorios Rubio SA, Castellbisbal, Barcelona, Spain
Product: Rubifen
Active Ingredient: Methylphenidate hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Laboratorios Rubio SA, Castellbisbal, Barcelona, Spain
Product: Scholl Callous Removal Pads
Active Ingredient: Salicylic acid 40%w/w
Dosage Form: Medicated dressing
New Zealand Sponsor: SSL New Zealand Limited
Manufacturer: SSL International? Plc, Derby, Derbyshire, United Kingdom
Product: Scholl Corn Removal Pads
Active Ingredient: Salicylic acid 40%w/w
Dosage Form: Medicated dressing
New Zealand Sponsor: SSL New Zealand Limited
Manufacturer: SSL International Plc, Derby, Derbyshire, United Kingdom
Product: Scholl Corn Removal Plasters (Fabric)
Active Ingredient: Salicylic acid 40%w/w
Dosage Form: Medicated dressing
New Zealand Sponsor: SSL New Zealand Limited
Manufacturer: SSL International Plc, Derby, Derbyshire, United Kingdom
Product: Scholl Corn Removal Plasters (Washproof)
Active Ingredient: Salicylic acid 40%w/w
Dosage Form: Medicated dressing
New Zealand Sponsor: SSL New Zealand Limited
Manufacturer: SSL International Plc, Derby, Derbyshire, United Kingdom
Product: Scholl Medicated Corn Remover
Active Ingredient: Salicylic acid 40%w/w
Dosage Form: Medicated dressing
New Zealand Sponsor: SSL New Zealand Limited
Manufacturer: SSL International Plc, Derby, Derbyshire, United Kingdom
Product: Scholl Soft Corn Removal Pads
Active Ingredient: Salicylic acid 12%w/w
Dosage Form: Medicated dressing
New Zealand Sponsor: SSL New Zealand Limited
Manufacturer: SSL International Plc, Derby, Derbyshire, United Kingdom
Product: Scholl Wart Removal System
Active Ingredient: Salicylic acid 40%w/w
Dosage Form: Medicated dressing
New Zealand Sponsor: SSL New Zealand Limited
Manufacturer: SSL International Plc, Derby, Derbyshire, United Kingdom
Product: Serevent Inhaler (CFC-free)
Active Ingredient: Salmeterol xinafoate 36.3µg/dose equivalent to salmeterol 25µg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Wellcome Production, Evreux, France
Product: Yentreve
Active Ingredient: Duloxetine hydrochloride 44.9mg equivalent to duloxetine base 40mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Eli Lilly and Co, Lilly Technology Centre, Indianapolis, Indiana, United States of America
Dated this 18th day of March 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).