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Cessatech Reports EU Committee Maintains Negative Opinion on Pediatric Pain Treatment

MT Newswires·11/13/2026 04:36:28
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04:36 AM EST, 11/13/2026 (MT Newswires) -- Cessatech (CETX.ST) said the European Medicines Agency's Committee for Medicinal Products for Human Use maintained its negative opinion on Proveca's marketing authorization application for CT001/KemSu as a ketamine/sufentanil nasal spray for acute pain in children, after a re-examination. The Danish pharmaceutical company and its commercialization partner plan to seek scientific advice from the EMA to clarify outstanding evidence gaps and determine the additional data needed for a potential resubmission, according to a Friday release. Cessatech added that the CHMP had removed one of the two original grounds for refusal, leaving one regulatory issue to address.