Imvanex (smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara))
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)
- Company
- Bavarian Nordic A/S
- Status
- Authorised
- Therapeutic area
- Smallpox Vaccine; Monkeypox virus
- CHMP opinion
- Thu 30 May 2013
- EU approval
- Wed 31 Jul 2013
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/002596
- ATC
- J07BX
- Official record
- www.ema.europa.eu
Indication
Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in individuals 2 years of age and older. The use of this vaccine should be 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.