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:
Product: BayHep B
Active Ingredient(s): Hepatitis B immunoglobulin (human) 217IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited Health Care Division
Manufacturer(s): Bayer Corporation, 8368 U.S. 70 West, Clayton, North Carolina 27250, United States of America
This consent is given subject to the following conditions:
? Provisional consent under section 23 of the Medicines Act 1981 will only be valid for a period of 2 years.
? Other conditions may be imposed from time to time by the Director-General of Health in respect to the supply, distribution and use of this medicine.
Note: This consent is valid for 2 years from the date of publication of this notice.
Dated this 5th day of December 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).