Active substance: voxelotor With the publication of the European Commission's decision on 9 December 2025, the risk assessment procedure for Oxbryta (voxelotor) was completed. 

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 58778/25

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 56721/25

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 52059/25

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 53565/25

Product group Active implantable medical devices - implantats emitting radioactive radiation
Reference 58876/25

Active substance: tranexamic acid The marketing authorisation holders inform that injectable tranexamic acid formulations are only authorised for intravenous use.

Product group Radiological technology - CT scanners
Reference 56698/25

Product group Medical instruments for use in humans - bone surgery
Reference 57313/25

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 57196/25

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 56186/25

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 53899/25

Structure of the BfArM (date 08.12.2025)

Structure of the BfArM (date 08.12.2025)

Product group Non-active implants - bone surgery
Reference 52569/25

Product group Medical instruments for use in humans - visceral surgery
Reference 57622/25

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 56666/25

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 55937/25

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 54741/25

Product group Active implantable medical devices - biostimulators
Reference 57515/25