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 + Night Cough Cold + Flu
Day Capsule
Active Ingredients: Dextromethorphan hydrobromide monohydrate 10mg
Paracetamol 300mg
Phenylephrine hydrochloride 5mg
Dosage Form: Liquid filled capsule
Night Capsule
Active Ingredients: Chlorphenamine maleate 2mg
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 Night Relief Cough Cold + Flu
Active Ingredients: Chlorphenamine maleate 2mg
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: Histaclear
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sigma Laboratories Limited, Goa, India
Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Marksans Pharma Limited, Goa, India
Product: Loraclear Hayfever Relief
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sigma Laboratories Limited, Goa, India
Product: Nivestim
Active Ingredient: Filgrastim 0.12mg/0.2mL
Dosage Form: Solution for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Zagreb d.o.o, Zagreb, Croatia
Product: Nivestim
Active Ingredient: Filgrastim 0.3mg/0.5mL
Dosage Form: Solution for injection
New Zealand Sponsor: Hospira NZ Ltd
Manufacturer: Hospira Zagreb d.o.o, Zagreb Croatia
Product: Nivestim
Active Ingredient: Filgrastim 0.48mg/0.5mL
Dosage Form: Solution for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Zagreb d.o.o, Zagreb, Croatia
Product: Zarzio
Active Ingredient: Filgrastim 0.3mg/0.5mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: IDT Biologika GmbH, Dessau Rosslau, Germany
Product: Zarzio
Active Ingredient: Filgrastim 0.48mg/0.5mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: IDT Biologika GmbH, Dessau Rosslau, Germany
Dated this 16th day of May 2012.
DR DON MACKIE, 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).