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: Intragam P
Active Ingredient(s): Immunoglobulin G 0.06g/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Naropin
Active Ingredient(s): Ropivacaine hydrochloride (monohydrate) 10.6mg/mL equivalent to 10mg/mL Ropivacaine Hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
AstraZeneca Pty Ltd, North Ryde, New South Wales, Australia
Product: Naropin
Active Ingredient(s): Ropivacaine hydrochloride (monohydrate) 2.12mg/mL equivalent to 2mg/mL Ropivacaine Hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
AstraZeneca Pty Ltd, North Ryde, New South Wales, Australia
NPBI BV, Runde, Emmer-Compascuum, The Netherlands
Product: Naropin
Active Ingredient(s): Ropivacaine hydrochloride (monohydrate) 7.93mg/mL equivalent to 7.5mg/mL Ropivacaine Hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
AstraZeneca Pty Ltd, North Ryde, New South Wales, Australia
Dated this 5th day of January 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).