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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

Casgevy

Vertex Pharmaceuticals (Ireland) Limited

EU/1/23/1787 09.02.2024

EPAR: Casgevy

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. 518 in BAnz AT 26.06.2024 B7.

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: 26.06.2024