Marketing Authorisation Application (MAA) for CT001 has been submitted to the European Medicines Agency (EMA) for acute pain management in children

The Marketing Authorisation Application (MAA) for CT001 is submitted to the European Medicines Agency… The Marketing Authorisation Application (MAA) for CT001 is submitted to the European Medicines Agency (EMA) for acute pain management in children Proveca has submitted a Paediatric Use Marketing Authorisation (PUMA) application for CT001 (ketamine/sufentanil nasal spray) to the EMA The validation process has been completed The review process will now be initiated and potential approval expected in 2026 Copenhagen, Denmark – 14 August 2025 – Cessatech A/S (“Cessatech”) and Proveca Ltd (“Proveca”) today announce that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for CT001 (a prescription only medicine), confirming that the submission is complete and that the formal scientific review has started. This event marks a significant milestone in Proveca’s and Cessatech’s mission to bring an innovative treatment candidate to paediatric patients in Europe. Link to Release Related articles 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 24. July, 2026 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... 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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