Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:
Schedule
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
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 80mg/mL
Ritonavir 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Aesica Pharmaceuticals Limited, Queenborough, Kent, United Kingdom
Dated this 13th day of November 2009
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).