Cell and gene therapy Medicines Approved in the EU (EMA)

• 47medicines authorised in the EU (authorised now)

Each number has its full source under its own list below.

• 9Jan2026

  Waskyra

  Active substance: genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentivi…

  EMEA/H/C/006525
• 25Aug2025

  Zemcelpro

  Active substance: allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel

  EMEA/H/C/005772
• 12Feb2025

  Zefylti

  Active substance: filgrastim

  EMEA/H/C/006400
• 9Feb2024

  Casgevy

  Active substance: Exagamglogene autotemcel

  EMEA/H/C/005763
• 5Jan2024

  Azacitidine Kabi

  Active substance: azacitidine

  EMEA/H/C/006154
• 7Jul2023

  Columvi

  Active substance: Glofitamab

  EMEA/H/C/005751
• 16Dec2022

  Plerixafor Accord

  Active substance: Plerixafor

  EMEA/H/C/005943
• 9Nov2022

  Livtencity

  Active substance: Maribavir

  EMEA/H/C/005787
• 17Aug2022

  Pepaxti

  Active substance: Melphalan flufenamide hydrochloride

  EMEA/H/C/005681
• 26Aug2021

  Minjuvi

  Active substance: tafasitamab

  EMEA/H/C/005436
• 17Jun2021

  Onureg

  Active substance: azacitidine

  EMEA/H/C/004761
• 26Mar2021

  Thiotepa Riemser

  Active substance: thiotepa

  EMEA/H/C/005434
• 11Feb2021

  Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)

  Active substance: lenalidomide hydrochloride monohydrate

  EMEA/H/C/005348
• 11Feb2021

  Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)

  Active substance: lenalidomide hydrochloride monohydrate

  EMEA/H/C/005734
• 18Dec2020

  Lenalidomide Mylan

  Active substance: lenalidomide

  EMEA/H/C/005306

Source: European Medicines Agency, Centrally authorised human medicines (EPAR), authorised now. Retrieved 12 Nov 2026.

• Oncology
• Biologics and biosimilars