Abrysvo (respiratory syncytial virus vaccine (bivalent, recombinant))
- Region
- 🇪🇺 EU
- Active substance
- respiratory syncytial virus vaccine (bivalent, recombinant)
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Respiratory Syncytial Virus Infections
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Wed 23 Aug 2023
- Designations
- Accelerated assessment, Additional monitoring
- Application
- EMEA/H/C/006027
- ATC
- J07BX05
- Official record
- www.ema.europa.eu
Indication
Abrysvo is indicated for: Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. Active immunisation of individuals 18 years of age and older for the prevention of lower respiratory tract disease caused by RSV. 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.