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: Arrow – Terbinafine
Active Ingredient: Terbinafine hydrochloride 281.25mg equivalent to 250mg terbinafine
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Arrow Pharm (Malta) Limited, Hal Far, Malta
Faco Ilaclari AS, Levant, Istanbul, Turkey
Product: Flomaxtra
Active Ingredient: Tamsulosin hydrochloride 400µg
Dosage Form: Modified release tablet
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: Astellas Pharma Europe B.V., Meppel, The Netherlands
Product: m-Fluconazole
Active Ingredient: Fluconazole 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Pharmathen SA, Pallini, Attikis, Greece
Product: Strepsils Lemon Sugar Free
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: The Boots Company Plc., Beeston, Nottingham, Nottinghamshire, United Kingdom
Product: Sudafed PE Phenylephrine Nasal Decongestant (Pharmacy Only)
Active Ingredient: Phenylephrine hydrochloride 10mg equivalent to 8.2mg phenylephrine
Dosage Form: Tablet
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer: Pfizer Australia Pty Limited, West Ryde, New South Wales, Australia
Product: Atacand
Active Ingredient: Candesartan cilexetil 32mg
Dosage Form: Tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Snackviken, Sodertalje, Sweden
Dated this 17th day of May 2006.
KAREN MITCHELL, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).