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Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics

Active Substance: influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1)
Common Name: prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
ATC Code: J07BB02
Marketing Authorisation Holder: Novartis Vaccines and Diagnostics S.r.l.
Active Substance: influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1)
Status: Withdrawn
Authorisation Date: 2010-11-29
Therapeutic Area: Influenza, Human Immunization Disease Outbreaks
Pharmacotherapeutic Group: Vaccines

Therapeutic Indication

Active immunisation against H5N1 subtype of Influenza A virus.

This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain.

Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic  should be used in accordance with official recommendations.

The marketing authorisation for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics has expired following the marketing-authorisation holder's decision not to apply for a renewal.

Source: European Medicines Agency

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