SNY CHMP opinion: Thursday, September 17, 2026

CompanySanofi (SNY)
EventCHMP opinion
DateThursday, September 17, 2026
MarketUS listing
SourceEMA CHMP · confidence 90% · primary source ↗

Variation type II · Teizeild · Update of section 4.4 of the SmPC in order to update the existing warning on serious infections in order to add Epstein-Barr Virus (EBV) reactivation in patients with co-morbid conditions predisposing them to significant immunocompromise, based on a safety evaluation r

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