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: Vaxigrip vaccine
Active Ingredients: Influenza virus A/Wellington/I/2004(H3N2)-like strain 10µg/dose
Influenza virus B/Shanghai/361/2002-like strain 15µg/dose
Influenza virus haemagglutin type A/New Caledonia/20/99 H1N1-like strain 15µg/dose
Dosage Form: Solution for injection
New Zealand Sponsor: Aventis Pharma Limited
Manufacturers: Aventis Pasteur SA, Marcy L’Etoile, France
Aventis Pasteur SA, Val-De-Reuil Cedex, France
Note: This consent is given subject to the following conditions:
? The vaccine is approved as a single dose of vaccine for administration to individuals age under 65 years who are at
low-risk from either influenza infection or the complications of influenza infection.
? The vaccine must be distributed with an appropriate and agreed “Dear Doctor” letter.
Note: This consent is valid until 31 March 2006.
Dated this 11th day of April 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).