Proveca intends to request a re-examination of CHMP opinion for CT001/KemSu

See also the updated Q&A documentation related to the Release: Link The European Medicines… See also the updated Q&A documentation related to the Release: Link The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the Paediatric Use Marketing Authorisation (PUMA) application for CT001/KemSu (intranasal sufentanil/ketamine). Proveca intends to request a re-examination of the CHMP opinion in accordance with EMA procedures. Proveca and Cessatech remain committed to working closely with the EMA throughout the re-examination process. CT001/KemSu continues to represent an important potential treatment option for children with moderate to severe acute pain Jes Trygved, C EO of Cessatech, said: “ While we are naturally disappointed by today’s opinion, we remain confident in the overall benefit-risk profile of KemSu and in the comprehensive data supporting the application. Together with our partner Proveca , we intend to request a re-examination of the CHMP opinion and will continue to work constructively with the EMA, with the objective of making KemSu available to children who need new treatment options for the management of acute pain. The re-examination process is expected to take several months . ” See the full Release Related articles Releases 27. September, 2026 EUSEM Press release: Nasal spray brings pain relief for children treated in the emergency department Paris, France: A treatment for pain, that is delivered via a nasal spray, offers... Read more Releases 27. August, 2026 CT001 ready for shipment to initial U.S. hospitals as launch activities commence Initial U.S. commercial supply of CT001 now available for shipment Launch activities initiated with... Read more Releases 12. June, 2026 Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet, to advance an intravenous formulation of melatonin for post-anaesthesia delirium (CT004) in children ... Read more Stay up to date! Subscribe and get notified on Cessatech's latest news. An acceptance email will be sent to you, please check your spam. Please leave this field empty Almost there! Please check your inbox to confirm your subscription to Cessatech.

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