Paul-Ehrlich-Institut

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

Gly­bera

uniQure bio­phar­ma B.V., Nieder­lande

EU/1/12/791/001 25.10.2012

EPAR: Gly­bera

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

Spark Ther­a­peu­tics Ire­land Ltd., IRL

EU/1/18/1331 22.11.2018

EPAR: Lux­tur­na

Strimvelis

Glax­o­SmithK­line Trad­ing Ser­vices Lim­it­ed, IRL

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

Yescar­ta

Kite Phar­ma EU B.V., NL

EU/1/18/1299 23.08.2018

EPAR: Yescar­ta

Zol­gens­ma

AveX­is EU Lim­it­ed, Dublin

EU/1/20/1443 18.05.2020

EPAR: Zol­gens­ma

Zyn­te­glo

blue­bird bio (Nether­lands) B.V., Utrecht

EU/1/19/1367 29.05.2019

EPAR: Zyn­te­glo

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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. 481 in BAnz AT 07.05.2021 B9.

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: 07.05.2021