Mvabea (Ebola vaccine (MVA-BN-Filo [recombinant]))
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- Ebola vaccine (MVA-BN-Filo [recombinant])
- Status
- Withdrawn
- Therapeutic area
- Hemorrhagic Fever, Ebola
- CHMP opinion
- Thu 28 May 2020
- EU approval
- Wed 01 Jul 2020
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005343
- ATC
- J07BX
- Official record
- www.ema.europa.eu
Indication
Mvabea, as part of the Zabdeno, Mvabea vaccine regimen, is indicated for active immunisation for prevention of disease caused by Ebola virus (Zaire ebolavirus species) in individuals ≥ 1 year of age (see sections 4.4 and 5.1).
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.