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Approvals & Trials

Merck receives positive CHMP opinion to extend Enflonsia use to children up to 24 months

Merck has received a positive EU CHMP opinion to expand the marketing authorisation for Enflonsia (clesrovimab) to children up to 24 months who remain vulnerable to severe RSV disease.

“Children Up to 24 Months of Age Who Remain Vulnerable to Severe RSV Disease Through Their Second RSV Season”— Business Wire

Merck has received a positive opinion from the EU CHMP to expand the marketing authorisation for Enflonsia (clesrovimab), according to a Business Wire item published on 13 November 2026.

The expansion would include children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season, according to the headline of the announcement.

The text available for this report consisted of the headline only. It gave no supporting data, no product or dosing details and no information on next regulatory steps, so none are reported here.

Original source

Merck Receives Positive EU CHMP Opinion to Expand Marketing Authorization for ENFLONSIA® (clesrovimab) to Include Children Up to 24 Months of Age Who Remain Vulnerable to Severe RSV Disease Through Their Second RSV Season https://news.google.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?oc=5

#paediatrics#therapeutics#policy

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