Immunoglobulin Preparations
Immunoglobulin preparations are produced from human blood and contain a number of quite different antibodies (polyclonal antibodies).
Name
|
Marketing Authorisation Holder
|
License Number
|
License Date
|
Use
|
Further Information
|
Biseko
|
Humanes Normalserumpräparat
|
Biotest Pharma GmbH
|
32a/78 |
01.08.1980 |
intravenös |
PharmNet.Bund
|
Pentaglobin
|
Immunglobulin vom Menschen
|
Biotest Pharma GmbH
|
170a/90 |
23.10.1990 |
intravenös |
PharmNet.Bund
|
Tetagam P
|
Tetanus-Ig
|
CSL Behring GmbH
|
108a/89 |
22.09.1992 |
intramuskulär |
PharmNet.Bund
|
Berirab
|
Tollwut-Ig
|
CSL Behring GmbH
|
107a/89 |
22.09.1992 |
intramuskulär |
PharmNet.Bund
|
Hepatitis-B-Immunglobulin Behring
|
Hepatitis-B-Ig
|
CSL Behring GmbH
|
105a/89 |
22.09.1992 |
intramuskulär |
PharmNet.Bund
|
Gammagard S/D
|
Normales Immunglobulin vom Menschen
|
Shire Deutschland GmbH
|
186a/92 |
14.04.1994 |
intravenös |
PharmNet.Bund
|
Beriglobin
|
Immunglobulin G vom Menschen
|
CSL Behring GmbH
|
176a/92 |
22.09.1997 |
subkutan, intramuskulär |
PharmNet.Bund
|
Varitect CP
|
Varicella Zoster-Ig
|
Biotest Pharma GmbH
|
203a/95 |
21.12.1999 |
intravenös |
PharmNet.Bund
|
Cytotect CP Biotest
|
Cytomegalie-Ig
|
Biotest Pharma GmbH
|
6a/96 |
07.01.2000 |
intravenös |
PharmNet.Bund
|
Hepatect CP
|
Hepatitis-B-Immunglobulin vom Menschen
|
Biotest Pharma GmbH
|
72a/96 |
18.04.2000 |
intravenös |
PharmNet.Bund
|
Rhophylac 300
|
Anti-D-Ig
|
CSL Behring GmbH
|
PEI.H.00399.02.1 |
15.03.2001 |
intramuskulär, intravenös |
PharmNet.Bund
|
Gamunex 10%
|
Normales Immunglobulin vom Menschen
|
Grifols Deutschland GmbH (FfM)
|
PEI.H.02726.01.1 |
20.02.2004 |
intravenös |
PharmNet.Bund
|
Gammanorm 165 mg/ml Injektionslösung
|
Normales Immunglobulin vom Menschen
|
Octapharma GmbH
|
PEI.H.03070.01.1 |
19.06.2004 |
subkutan, intramuskulär |
PharmNet.Bund
|
Intratect
|
Normales Immunglobulin vom Menschen
|
Biotest Pharma GmbH
|
PEI.H.02901.01.1 |
27.09.2004 |
intravenös |
PharmNet.Bund
|
KIOVIG
|
Normales Immunglobulin vom Menschen
|
Baxter AG
|
EU/1/05/329/ 001-006 |
19.01.2006 |
intravenös |
EPAR: Kiovig
|
Rhesonativ
|
Anti-D-Ig
|
Octapharma GmbH
|
PEI.H.03287.01.1 |
20.03.2006 |
intramuskulär |
PharmNet.Bund
|
Ig Vena 50g/l Infusionslösung
|
Normales Immunglobulin vom Menschen
|
Kedrion S.p.A.
|
PEI.H.03409.01.1 |
02.02.2007 |
intravenös |
PharmNet.Bund
|
Flebogammadif
|
Normales Immunglobulin vom Menschen
|
Instituto Grifols, S.A.
|
EU/1/07/404/ 001-005 |
23.08.2007 |
intravenös |
EPAR: Flebogammadif
|
Flebogamma DIF
|
Normales Immunglobulin vom Menschen
|
Instituto Grifols, S.A.
|
EU/1/07/404/ 001-008 |
23.08.2007 |
intravenös |
EPAR: Flebogammadif
|
Privigen
|
Normales Immunglobulin vom Menschen (IVIg)
|
CSL Behring GmbH
|
EU/1/08/446/001-005 |
25.04.2008 |
intravenös |
EPAR: Privigen
|
Octagam 10%
|
Normales Immunglobulin vom Menschen (IVIg)
|
Octapharma GmbH
|
PEI.H.03627.01.1 |
20.05.2008 |
intravenös |
PharmNet.Bund
|
VENBIG
|
Humanes Hepatitis-B-Immunglobulin
|
Kedrion S.p.A.
|
PEI.H.04266.01.1 |
17.08.2009 |
intravenös |
PharmNet.Bund
|
Intratect
|
Normales Immunglobulin vom Menschen
|
CC Pharma GmbH
|
PEI.H.07961.01.1 |
14.09.2009 |
intravenös |
PharmNet.Bund
|
Rhophylac 200
|
Anti-D Immunglobulin vom Menschen
|
CSL Behring GmbH
|
PEI.H.00399.03.1 |
05.11.2009 |
intramuskulär, intravenös |
PharmNet.Bund
|
Zutectra
|
Hepatitis-B-Immunglobulin vom Menschen
|
Biotest Pharma GmbH
|
EU/1/09/600/001 |
30.11.2009 |
subkutan |
EPAR: Zutectra
|
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. 519 in BAnz AT 26.07.2024 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.