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: Chirocaine
Active Ingredient(s): Levobupivacaine hydrochloride 2.816mg/mL equivalent to 2.5mg/ml levobupivacaine
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Antigen Pharmaceuticals Limited, Roscrea, Co. Tipperary, Eire
Note: This consent is valid for 2 years from the date of publication of this notice.
Product: Chirocaine
Active Ingredient(s): Levobupivacaine hydrochloride 5.633mg/mL equivalent to 5mg/mL levobupivacaine
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Antigen Pharmaceuticals Limited, Roscrea, Co. Tipperary, Eire
Note: This consent is valid for 2 years from the date of publication of this notice.
Product: Chirocaine
Active Ingredient(s): Levobupivacaine hydrochloride 8.449mg/mL equivalent to 7.5mg/mL levobupivacaine
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Antigen Pharmaceuticals Limited, Roscrea, Co. Tipperary, Eire
Note: This consent is valid for 2 years from the date of publication of this notice.
Dated this 7th day of May 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).