The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended withdrawing the mpox indication for Siga Technologies’ tecovirimat, while keeping approval for smallpox, cowpox, and adverse reactions to vaccinia vaccines. The action follows CHMP’s review of the antiviral’s label after use in patients during recent mpox outbreaks. For commercialization and procurement planning, the decision narrows where tecovirimat can be promoted and reimbursed across European markets for mpox-specific use. It also underscores how quickly label positions can change once outbreak data, clinical outcomes, and public-health assumptions are revisited. Market participants will likely focus on whether Siga pursues additional evidence for mpox or shifts strategy toward its remaining approved indications.