Enflonsia (clesrovimab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- clesrovimab
- Company
- Merck Sharp Dohme Limited
- Status
- Authorised
- Therapeutic area
- Respiratory Syncytial Virus Vaccines
- CHMP opinion
- Thu 18 Sep 2025
- EU approval
- Wed 15 Apr 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006497
- ATC
- J06BD10
- Official record
- www.ema.europa.eu
Indication
Enflonsia is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.Enflonsia should be used in accordance with official recommendations.
Regulatory milestones
Wed 15 Apr 2026🇪🇺 EU approval (EC decision)
Enflonsia (clesrovimab) approved in the EU
Marketing authorisation to Merck Sharp Dohme Limited; Additional monitoring · source
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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.