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: Amisulpride 100 Winthrop
Active Ingredient: Amisulpride 100mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis New Zealand Limited
Manufacturers: Sanofi Winthrop Industrie, Quetigny, France
Sanofi-Synthelabo Limited, Fawdon, Newcastle-upon-Tyne, Tyne & Wear, United Kingdom
Product: Amisulpride 200 Winthrop
Active Ingredient: Amisulpride 200mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis New Zealand Limited
Manufacturers: Sanofi Winthrop Industrie, Quetigny, France
Sanofi-Synthelabo Limited, Fawdon, Newcastle-upon-Tyne, Tyne & Wear, United Kingdom
Product: Amisulpride 400 Winthrop
Active Ingredient: Amisulpride 400mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis New Zealand Limited
Manufacturers: Sanofi Winthrop Industrie, Quetigny, France
Sanofi-Synthelabo Limited, Fawdon, Newcastle-upon-Tyne, Tyne & Wear, United Kingdom
Product: Amisulpride 50 Winthrop
Active Ingredient: Amisulpride 50mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis New Zealand Limited
Manufacturers: Sanofi Winthrop Industrie, Quetigny, France
Sanofi-Synthelabo Limited, Fawdon, Newcastle-upon-Tyne, Tyne & Wear, United Kingdom
Product: Amisulpride Winthrop
Active Ingredient: Amisulpride 100mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: sanofi-aventis New Zealand Limited
Manufacturer: Sanofi Winthrop Industrie, Colomiers, France
Product: Budesonide Clickhaler 100µg
Active Ingredient: Budesonide 1.625%w/w
Dosage Form: Powder for inhalation
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Ashton Pharmaceuticals Limited, Ashton-Under-Lyne, Lancashire, United Kingdom
Product: Budesonide Clickhaler 200µg
Active Ingredient: Budesonide 3.25%w/w
Dosage Form: Powder for inhalation
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Ashton Pharmaceuticals Limited, Ashton-Under-Lyne, Lancashire, United Kingdom
Product: Budesonide Clickhaler 400µg
Active Ingredient: Budesonide 6.5%w/w
Dosage Form: Powder for inhalation
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Ashton Pharmaceuticals Limited, Ashton-Under-Lyne, Lancashire, United Kingdom
Product: Dantrium
Active Ingredient: Dantrolene sodium 25mg
Dosage Form: Capsule, powder filled
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Procter & Gamble Pharmaceuticals Puerto Rico Inc, Bo. Cotto Norte, Puerto Rico
Product: Dantrium
Active Ingredient: Dantrolene sodium 50mg
Dosage Form: Capsule, powder filled
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Procter & Gamble Pharmaceuticals Puerto Rico Inc, Bo. Cotto Norte, Manati, Puerto Rico
Product: Zantac Relief Extra Strength
Active Ingredient: Ranitidine hydrochloride 336mg equivalent ranitidine 300mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Boronia, Victoria, Australia
Dated this 31st day of August 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).