Vepacel (prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture))
- Region
- 🇪🇺 EU
- Active substance
- prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)
- Company
- Ology Bioservices Ireland LTD
- Status
- Withdrawn
- Therapeutic area
- Influenza, Human; Immunization; Disease Outbreaks
- EU approval
- Fri 17 Feb 2012
- Application
- EMEA/H/C/002089
- ATC
- J07BB01
- Official record
- www.ema.europa.eu
Indication
Active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. Vepacel should be used in accordance with Official guidance.
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.