Published: 14. August, 2025
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.
