Record mula sa primary source
Decision-gradeOpinyon ng EMA
Merck: Inaprubahan ng EC ang ENFLONSIA (clesrovimab) para sa pag-iwas sa RSV sa sanggol
Nagbigay ang European Commission ng marketing authorization para sa ENFLONSIA (clesrovimab) sa lahat ng 27 miyembrong estado ng EU kasama ang Iceland, Liechtenstein at Norway. Ito ang unang at tanging RSV preventive monoclonal antibody na inaprubahan sa EU na gumagamit ng fixed, non-weight-based 105 mg na dosis para sa lahat ng sanggol na papasok sa kanilang unang RSV season.
Mahahalagang fact
- Na-file
- Abr 17, 2026, 11:49 AM
- Kaganapan
- Opinyon ng EMA
- Direksyon
- Positibo
- Kumpanya
MRKMSD- Asset
- clesrovimab-cfor
- Pinagmulan
- Press release ng kumpanya
- Kumpiyansa
- May source
- pagbabawas ng malri
- 60.4% (95% CI: 44.1, 71.9)
- pagbabawas ng malubhang malri
- 91.7% (95% CI: 62.9, 98.1)
- pagbabawas ng pagpapaospital
- 84.2% (95% CI: 66.6, 92.6)
- pagbabawas ng pagpapaospital dahil sa lri
- 90.9% (95% CI: 76.2, 96.5)
Sipi mula sa source
European Commission Approves Merck's ENFLONSIA(TM) (clesrovimab) for the Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants During Their First RSV Season European Commission Approves Merck's ENFLONSIA(TM) (clesrovimab) for the Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants During Their First RSV Season European Commission Approves Merck’s ENFLONSIA™ (clesrovimab) for the Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants During Their First RSV Season ENFLONSIA is the first and only RSV preventive option in the European Union for administration to infants without the need for weight-based dosing Merck (NYSE: MRK), known as MSD outside of the United States and Canad
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Materyal
Ago 6, 2026
10:45 AM
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