AcuCort receives renewed marketing authorisation for Zeqmelit® in Denmark

The pharmaceutical company AcuCort has received a renewed marketing authorisation for its medicinal product Zeqmelit® from the Danish Medicines Agency (Lægemiddelstyrelsen), Denmark’s equivalent of the Swedish Medical Products Agency. The decision grants approval without a time limitation.

AcuCort was first granted a marketing authorisation for Zeqmelit® in Denmark in 2022. That approval was time-limited, which is standard for new medicines. Now, following an inspection by the Swedish Medical Products Agency, the Danish Medicines Agency has granted an extended marketing authorisation, this time without a time restriction.
 

– The decision was expected, but it is still an important milestone as we prepare for our upcoming expansion in the Danish market, says AcuCort’s CEO, Jonas Jönmark.

For further information: 
Jonas Jönmark, vd, AcuCort AB
Phone: 070 365 5400
E-mail: [email protected]

About AcuCort AB (publ)
AcuCort has developed and is commercializing Zeqmelit®, a new rapidly dissolving oral film placed on the tongue, based on the well-known cortisone substance dexamethasone. The drug is a smart product in a new, innovative, patented, and user-friendly administration form primarily for the treatment of severe and acute allergic reactions, croup in children, nausea and vomiting during chemotherapy, and for the treatment of patients with COVID-19 requiring supplemental oxygen therapy. Zeqmelit® is approved in Sweden, Denmark, Norway, and Finland. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market. Visit www.acucort.se for more information.