Gene Ther­a­py Medic­i­nal Prod­ucts

Gene therapeutics are biological medicinal products. Their active ingredients contain or extis of a nucleic acid (carrier of the genetic information). Gene therapeutics are used to regulate, repair, replace, add to, or remove a nucleic acid sequence. The therapeutic, preventative, and diagnostic effect is in direct connection to the recombinant nucleic acid sequence which the product contains or in direct connection with the product which is formed on the basis of this genetic information.

Name Mar­ket­ing Au­tho­ri­sa­tion Hold­er Li­cense Num­ber Li­cense Date Further Information


Cel­gene Eu­rope B.V., NL

EU/1/21/1539 18.08.2021

EPAR: Abec­ma


uniQure bio­phar­ma B.V., Nieder­lande

EU/1/12/791/001 25.10.2012

EPAR: Gly­bera


Am­gen Eu­rope B.V.

EU/1/15/1064 16.12.2015

EPAR: Im­ly­g­ic


No­var­tis Eu­ropharm Ltd., IRL

EU/1/18/1297 23.08.2018

EPAR: Kym­ri­ah


Or­chard Ther­a­peu­tics (Nether­lands) B.V., NL

EU/1/20/1493 17.12.2020

EPAR: Lib­meldy


No­var­tis Eu­ropharm Lim­it­ed

EU/1/18/1331 22.11.2018

EPAR: Lux­tur­na


Or­chard Ther­a­peu­tics B.V., NL

EU/1/16/1097 26.05.2016

EPAR: Strimvelis


Kite Phar­ma EU B.V., NL

EU/1/20/1492 14.12.2020

EPAR: Tecar­tus


Kite Phar­ma EU B.V., NL

EU/1/18/1299 23.08.2018

EPAR: Yescar­ta


AveX­is EU Lim­it­ed, Dublin

EU/1/20/1443 18.05.2020

EPAR: Zol­gens­ma


blue­bird bio (Nether­lands) B.V., Utrecht

EU/1/19/1367 29.05.2019

EPAR: Zyn­te­glo



The list of medicines contains the products that have a valid marketing authorization. It contains no information as to whether the preparations are available on the market.

The information contained in the Federal Gazette, which is the official publication organ of the Paul-Ehrlich-Institut, is legally binding.

As of: PEI announcement No. 492 in BAnz AT 06.04.2022 B6.

Summary of Product Characteristics (SmPCs) and the Package Leaflet (PL)

Where the European Medicines Agency (EMA) offers further information, you will find a link to the EPAR (European public assessment report) in the table.

If user and technical information or public assessment reports are available in PharmNet.Bund, the Federal and State Pharmaceutical Information Portal, these are directly linked to PharmNet.Bund in the table.

Updated: 03.06.2022