mResvia (respiratory syncytial virus mRNA vaccine)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- respiratory syncytial virus mRNA vaccine
- Company
- Moderna Biotech Spain, S.L.
- Status
- Authorised
- Therapeutic area
- Respiratory Syncytial Virus Infections
- CHMP opinion
- Thu 27 Jun 2024
- EU approval
- Thu 22 Aug 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006278
- ATC
- J07BX05
- Official record
- www.ema.europa.eu
Indication
mResvia is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults 18 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.