Paul-Ehrlich-Institut

Oth­er Blood Prod­ucts

Components of the blood that cannot be assigned to one of the other above-mentioned groups of medicines.

Name Mar­ket­ing Au­tho­ri­sa­tion Hold­er Li­cense Num­ber Li­cense Date Further Information

FEI­BA NF 500 E

Shire Deutsch­land GmbH

PEI.H.03340.01.1 12.12.2005

FEI­BA NF 1000 E

Shire Deutsch­land GmbH

PEI.H.03340.02.1 12.12.2005

Je­trea

Throm­bo­Gen­ics NV, B-3001 Leu­ven

EU/1/13/819 13.03.2013

EPAR: JE­TREA

Rote-Hand-Brief: Je­trea - Ocriplas­min (21.08.2018)

Nor­mosang

Recor­dati Rare Dis­eases

PEI.H.03381.01.1 15.10.2006

On­dexxya

Por­to­la Nether­lands B.V.

EU/1/18/1345 26.04.2019

EPAR: On­dexxya

Pro­lastin (Al­pha-1 Pro­teina­sein­hibitor)

Gri­fols Deutsch­land GmbH

12944.01.00 14.12.1988

Re­spreeza

CSL Behring GmbH

EU/1/15/1006 20.08.2015

EPAR: Re­spreeza

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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. 477 in BAnz AT 16.02.2021 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: 01.03.2021