Selected EMA news, December 2025

New information on approved medicines 

• Aspaveli (pegcetacoplan) – new indication – orphan 
  Treatment of paroxysmal nocturnal hemoglobinuria (PNH), an acquired disease in which there is excessive breakdown of red blood cells, leading to large amounts of hemoglobin being released into the urine 

Direct Healthcare Professional Communication (DHPC) 

• Tranexamic acid intravenous formulations – Serious, including fatal, adverse reactions due to inadvertent intrathecal administration 
  Prevention and treatment of excessive bleeding