Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Actigall
Active Ingredient: Ursodeoxycholic acid 300mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Watson Laboratories Inc, New York, United States of America
Watson Pharma Private Limited, Verna, India
Product: Apo-Risperidone
Active Ingredient: Risperidone 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturers: Apotex Inc, Etobicoke, Ontario, Canada
Apotex Inc, Weston, Ontario, Canada
Product: Apo-Risperidone
Active Ingredient: Risperidone 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturers: Apotex Inc, Etobicoke, Ontario, Canada
Apotex Inc, Weston, Ontario, Canada
Product: Apo-Risperidone
Active Ingredient: Risperidone 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturers: Apotex Inc, Etobicoke, Ontario, Canada
Apotex Inc, Weston, Ontario, Canada
Product: Apo-Risperidone
Active Ingredient: Risperidone 3mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturers: Apotex Inc, Etobicoke, Ontario, Canada
Apotex Inc, Weston, Ontario, Canada
Product: Apo-Risperidone
Active Ingredient: Risperidone 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturers: Apotex Inc, Etobicoke, Ontario, Canada
Apotex Inc, Weston, Ontario, Canada
Product: Kaletra
Active Ingredients: Lopinavir 80mg/mL
Ritonavir 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Aesica Queensborough Limited, Kent, United Kingdom
Product: Kaletra
Active Ingredients: Lopinavir 200mg
Ritonavir 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott GmbH & Co. KG, Ludwigshafen, Germany
Product: Kaletra
Active Ingredients: Lopinavir 100mg
Ritonavir 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott GmbH & Co. KG, Ludwigshafen, Germany
Dated this 22nd day of September 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).