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: Advil Infant’s Pain & Fever Relief
Active Ingredient: Ibuprofen 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Interphil Laboratories Inc, Laguna, Philippines
Product: Dimetapp PE Sinus Day + Night
Day Tablet
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
Night Tablet
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: Dimetapp PE Sinus Pain
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: Dimetapp PE Sinus Pain + Allergy
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: Healon Endocoat
Active Ingredient: Sodium hyaluronate 30mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AMO Australia Pty Limited
Manufacturer: Life Core Biomedical LLC, Minnesota, United States of America
Product: Iressa
Active Ingredient: Gefitinib 250mg
Dosage Form: Coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca UK Limited, Cheshire, United Kingdom
Product: OPTIVE Sensitive
Active Ingredients: Carmellose sodium 0.5%w/v
Glycerol 0.9%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals Ireland, Westport, Ireland
Product: Zaprone
Active Ingredient: Ziprasidone hydrochloride monohydrate 22.487mg equivalent to ziprasidone 20mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Zaprone
Active Ingredient: Ziprasidone hydrochloride monohydrate 44.974mg equivalent to ziprasidone 40mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Zaprone
Active Ingredient: Ziprasidone hydrochloride monohydrate 67.461mg equivalent to ziprasidone 60mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Zaprone
Active Ingredient: Ziprasidone hydrochloride monohydrate 89.948mg equivalent to ziprasidone 80mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Dated this 22nd day of July 2011.
MARK JACOBS, 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).