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: Dimetapp PE Day Relief Cough Cold + Flu (General Sale)
Active Ingredients: Dextromethorphan hydrobromide monohydrate 10mg
Paracetamol 300mg
Phenylephrine hydrochloride 5mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Catalent Australia Pty Limited, Braeside, Australia
Product: Dimetapp PE Day Relief Cough Cold + Flu (Pharmacy Only)
Active Ingredients: Dextromethorphan hydrobromide monohydrate 10mg
Paracetamol 300mg
Phenylephrine hydrochloride 5mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Catalent Australia Pty Limited, Braeside, Australia
Product: Dorzola Tim
Active Ingredients: Dorzolamide hydrochloride 22.26mg/mL equivalent to dorzolamide 20mg/mL
Timolol maleate 6.83mg/mL equivalent to timolol 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Famar SA, Athens, Greece
Product: Nurofen for Children 5-12 years (Concentrated Orange)
Active Ingredient: Ibuprofen 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom
Product: Nurofen for Children 5-12 years (Concentrated Strawberry)
Active Ingredient: Ibuprofen 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom
Product: Zypine® ODT
Active Ingredient: Olanzapine 5mg
Dosage Form: Wafer
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Zypine® ODT
Active Ingredient: Olanzapine 10mg
Dosage Form: Wafer
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Dated this 11th day of July 2012.
DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).