The ALIMS Approves Regkirona for Serbia with Zdravlje AD Leskovac as MA Holder
The Serbian Agency for Medicines (ALIMS) has approved on 02.08.2022 the Marketing Authorisation for Regkirona (regdanvimab) for Serbia with Zdravlje AD Leskovac as the Marketing Authorisation Holder.
Regkirona was one of the first monoclonal antibody medicines thar received The European Medicines Agency (EMA)’s authorisation on 12.11.2021 following a positive opinion from the CHMP for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. Regkirona contains the active substance regdanvimab.
“We are pleased to take yet another important step in building Zdravlje’s biologics business. We intend to continue addressing serious unmet medical needs through bringing further high-impact therapies to the region”, said Kiren Naidoo, CEO of Zdravlje.