Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Dukoral
Active Ingredient(s): Recombinant cholera toxin B sub unit 1mg
Vibrio cholerae Inaba 48 Classical biotype 25,000 million organisms
Vibrio cholerae Inaba 6973 El Tor biotype 25,000 million organisms
Vibrio cholerae Ogawa 50 Classical biotype 50,000 million organisms
Dosage Form: Oral suspension
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer(s): Recip AB, Arsta, Sweden
SBL Vaccin AB, Stockholm, Sweden
Dated this 20th day of February 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).