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: Apomine PFS
Active Ingredient: Apomorphine hydrochloride hemihydrate 5mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: S C Federa, Belgium
Product: Codral Cold & Flu + Cough Day & Night (Combination Pack)
Night Capsule
Active Ingredients: Chlorphenamine maleate 2mg
Dextromethorphan hydrobromide monohydrate 10mg equivalent to 7.3mg dextromethorphan
Paracetamol 500mg
Dosage Form: Capsule
Day Capsule
Active Ingredients: Dextromethorphan hydrobromide monohydrate 10mg equivalent to 7.3mg dextromethorphan
Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Capsule
New Zealand Sponsor: Johnson & Johnson Pacific (New Zealand) Limited
Manufacturer: Pfizer Australia Pty Limited, New South Wales, Australia
Product: Coldrex Hot Remedy Cold & Flu Hot Lemon
Active Ingredient: Paracetamol 1000mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Smithkline Beecham S.A. Carretera de Ajalvir, Alcal de Henares, Madrid, Spain
Product: Coldrex PE Phenylephrine Cold & Flu Night & Day (Combination Pack)
Night Tablet
Active Ingredients: Chlorphenamine maleate 2mg
Dextromethorphan hydrobromide monohydrate 15mg equivalent to 10.95mg dextromethorphan
Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Tablet
Day Tablet
Active Ingredients: Dextromethorphan hydrobromide monohydrate 15mg equivalent to 10.95mg dextromethorphan
Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia
Product: Demazin Paediatric Decongestant Nasal Drops
Active Ingredient: Oxymetazoline hydrochloride 0.25mg/mL
Dosage Form: Nasal drops
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Schering-Plough Mexico SA De CV, Xaltocan, Xochimilco, Mexico
Product: Drixine Paediatric Decongestant Nasal Drops
Active Ingredient: Oxymetazoline hydrochloride 0.25mg/mL
Dosage Form: Nasal drops
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Schering-Plough Mexico SA De CV, Xaltocan, Xochimilco, Mexico
Product: Tramedo SR
Active Ingredient: Tramadol hydrochloride 100mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Zentiva AS (Slovakia), Hlohovec, Slovakia
Product: Tramedo SR
Active Ingredient: Tramadol hydrochloride 150mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Zentiva AS (Slovakia), Hlohovec, Slovakia
Product: Tramedo SR
Active Ingredient: Tramadol hydrochloride 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Zentiva AS (Slovakia), Hlohovec, Slovakia
Dated this 5th day of January 2009.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).