Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted))
- Region
- 🇪🇺 EU
- Active substance
- prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
- Company
- Novartis Vaccines and Diagnostics S.r.l.
- Status
- Expired
- Therapeutic area
- Influenza, Human; Immunization; Disease Outbreaks
- EU approval
- Mon 29 Nov 2010
- Application
- EMEA/H/C/002269
- ATC
- J07BB02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.