Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Kaletra
Active Ingredient(s): Lopinavir 133.3mg
Ritonavir 33.3mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: R P Scherer Corporation, St Petersburg, Florida, United States of America
Note: This consent is valid for 2 years from the date of publication of this notice.
Product: Kaletra
Active Ingredient(s): Lopinavir 80mg/mL
Ritonavir 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott Laboratories Limited, Queenborough, Kent, United Kingdom
Note: This consent is valid for 2 years from the date of publication of this notice.
Dated this 16th day of January 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).