Sedana Medical’s Sedaconda (isoflurane) now approved in all 15 European countries included in the first submission
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that, following the national approval in Poland, the company has now received national market approvals in all 15 countries included in the Decentralised Procedure (DCP) approval received in July 2021.
The approvals apply to the drug Sedaconda (isoflurane) for administration via the medical device Sedaconda ACD for inhaled sedation of mechanically ventilated patients in intensive care. The applications have been approved by the national competent authorities in Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Ireland, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and Sweden. Outside the European Union, Sedaconda (isoflurane) has been approved in Switzerland.
Sedaconda (isoflurane) has been launched in several countries including Germany, France, Norway, Sweden and the Netherlands.
“It is very gratifying to see that all 15 countries included in the DCP approval see the value we bring to intensive care patients and have granted us their national approvals. With the anticipated additional approvals in Italy and the UK, we hope to soon be able to offer the first and only approved therapy for inhaled sedation in intensive care in all major European markets.” said Johannes Doll, CEO of Sedana Medical.
For additional information, please contact:
Johannes Doll, CEO, +46 (0)76 303 66 66
Johan Spetz, CFO, +46 (0)730 36 37 89
[email protected]
Sedana Medical is listed on Nasdaq First North Growth Market in Stockholm.
The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, [email protected].
About Sedana Medical
Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient’s life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care.
Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordic, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors.
Sedana Medical was founded in 2005, is listed on Nasdaq First North Growth Market (SEDANA) and headquartered in Stockholm, Sweden.