EMA · CAT · December 2025

List of Authorised ATMPs

Advanced Therapy Medicinal Products authorised by the European Medicines Agency

Gene Therapy (GTMP)
Cell Therapy (CTMP)
Tissue Engineered (TEP)
Active
Withdrawn / Not renewed
Opinion pending
Name Type Auth. Date Orphan PRIME Status / Comment
ChondrocelectTEP05 Oct 2009NoNoMA withdrawn Jul 2016
GlyberaGTMP25 Oct 2012YesNoMA not renewed (Oct 2017)
MACITEP / Combined27 Jun 2013NoNoMA not renewed (Jun 2018)
ProvengeCTMP06 Sep 2013NoNoMA withdrawn May 2015
HoloclarTEP17 Feb 2015YesNo
ImlygicGTMP16 Dec 2015NoNo
StrimvelisGTMP26 May 2016YesNo
ZalmoxisCTMP18 Aug 2016YesNoMA withdrawn Oct 2019
SpheroxTEP10 Jul 2017NoNo
AlofiselCTMP23 Mar 2018YesNoMA withdrawn Dec 2024
YescartaGTMP23 Aug 2018YesYes
KymriahGTMP23 Aug 2018YesYes
LuxturnaGTMP22 Nov 2018YesNo
ZyntegloGTMP29 May 2019YesYesMA withdrawn Mar 2022
ZolgensmaGTMP18 May 2020YesYes
LibmeldyGTMP17 Dec 2020YesNo
TecartusGTMP14 Dec 2020YesYes
SkysonaGTMP16 Jul 2021YesYesMA withdrawn Nov 2021
AbecmaGTMP18 Aug 2021YesYes
BreyanziGTMP04 Apr 2022NoYes
CarvyktiGTMP25 May 2022YesYes
UpstazaGTMP18 Jul 2022YesNo
RoctavianGTMP24 Aug 2022YesYes
EbvalloCTMP16 Dec 2022YesYes
HemgenixGTMP20 Feb 2023YesYes
CasgevyGTMP09 Feb 2024YesYes
BeqvezGTMP24 Jul 2024NoYesMA withdrawn May 2025
VyjuvekGTMP23 Apr 2025YesYes
AucatzylGTMP17 Jul 2025YesYes
ZemcelproCTMP25 Aug 2025YesYes
WaskyraGTMPOpinion Nov 2025YesNoPositive CHMP opinion adopted