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: Apo-Azithromycin
Active Ingredient: Azithromycin dihydrate 522.04mg equivalent to 500mg azithromycin
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Azithromycin
Active Ingredient: Azithromycin dihydrate 261.02mg equivalent to 250mg azithromycin
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Nicorette 16hr Invisipatch
Active Ingredient: Nicotine 23.62mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Nicorette 16hr Invisipatch
Active Ingredient: Nicotine 39.37mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Nicorette 16hr Invisipatch
Active Ingredient: Nicotine 15.75mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Nicotinell Classic
Active Ingredient: Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: Nicotinell Classic
Active Ingredient: Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: Panadol Caplet
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Dungarvan Limited, Waterford, Ireland
GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: Prezista
Active Ingredient: Darunavir 75mg equivalent to 81.31mg darunavir ethanolate
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Product: Prezista
Active Ingredient: Darunavir 150mg equivalent to 162.62mg darunavir ethanolate
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Dated this 12th day of March 2010.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).