Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Naropin
Active Ingredient: Ropivacaine hydrochloride monohydrate 5.29mg/mL equiv to 5mg/mL Ropivacaine hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Naropin
Active Ingredient: Ropivacaine hydrochloride monohydrate 7.93mg/mL equiv to 7.5mg/ml Ropivacaine hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca AB, Sodertalje, Sweden
AstraZeneca Pty Limited, North Ryde, New South Wales, Australia
Dated this 15th day of August 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).