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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

Abec­ma

Bris­tol-My­ers Squibb Phar­ma EEIG

EU/1/21/1539 18.08.2021

EPAR: Abec­ma

Breyanzi

Bris­tol Mey­ers Squibb Phar­ma EEIG, IR

EU/1/22/1631 04.04.2022

EPAR: Breyanzi

Carvyk­ti

Janssen-Cilag In­ter­na­tion­al N.V.

EU/1/22/1648 25.05.2022

EPAR: Carvyk­ti

Hem­genix

CSL Behring GmbH

EU/1/22/1715 20.02.2023

EPAR: Hem­genix

Im­ly­g­ic

Am­gen Eu­rope B.V.

EU/1/15/1064 16.12.2015

EPAR: Im­ly­g­ic

Kym­ri­ah

No­var­tis Eu­ropharm Ltd., IRL

EU/1/18/1297 23.08.2018

EPAR: Kym­ri­ah

Lib­meldy

Or­chard Ther­a­peu­tics (Nether­lands) B.V., NL

EU/1/20/1493 17.12.2020

EPAR: Lib­meldy

Lux­tur­na

No­var­tis Eu­ropharm Lim­it­ed

EU/1/18/1331 22.11.2018

EPAR: Lux­tur­na

Roc­ta­vian

BioMarin In­ter­na­tion­al Lim­it­ed, Ir­land

EU/1/22/1668 24.08.2022

EPAR: Roc­ta­vian

Strimvelis

Fon­dazione Telethon ETS

EU/1/16/1097 26.05.2016

EPAR: Strimvelis

Tecar­tus

Kite Phar­ma EU B.V., NL

EU/1/20/1492 14.12.2020

EPAR: Tecar­tus

Up­staza

PTC Ther­a­peu­tics In­ter­na­tion­al Lim­it­ed, Ir­land

EU/1/22/1653 18.07.2022

EPAR: Up­staza

Yescar­ta

Kite Phar­ma EU B.V., NL

EU/1/18/1299 23.08.2018

EPAR: Yescar­ta

Zol­gens­ma

No­var­tis Eu­ropharm Lim­it­ed, Dublin

EU/1/20/1443 18.05.2020

EPAR: Zol­gens­ma

Disclaimer

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. 514 in BAnz AT 01.03.2024 B8.

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: 04.03.2024