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
|
Gamunex 10%
|
Normales Immunglobulin vom Menschen (IVIg)
|
EMRA-MED Arzneimittel GmbH
|
PEI.H.11926.01.1 |
29.05.2019 |
intravenös |
|
Rhophylac 300
|
Anti-D (Rh) Immunglobulin
|
kohlpharma GmbH
|
PEI.H.11931.01.1 |
23.06.2017 |
intramuskulär, intravenös |
PharmNet.Bund
|
Intratect 100 g/l
|
Normales Immunglobulin vom Menschen (IVIg)
|
CC Pharma GmbH
|
PEI.H.11933.01.1 |
19.07.2017 |
intravenös |
PharmNet.Bund
|
Cutaquig
|
Normales Immunglobulin vom Menschen (SCIg)
|
Octapharma GmbH
|
PEI.H.11936.01.1 |
28.02.2019 |
subkutan |
PharmNet.Bund
|
Rhophylac 300
|
Anti-D (Rh) Immunglobulin
|
EMRA-MED Arzneimittel GmbH
|
PEI.H.11954.01.1 |
30.01.2019 |
intramuskulär, intravenös |
PharmNet.Bund
|
Rhophylac 300
|
Anti-D (Rh) Immunglobulin
|
EurimPharm Arzneimittel GmbH
|
PEI.H.11955.01.1 |
09.05.2018 |
intramuskulär, intravenös |
PharmNet.Bund
|
Rhophylac 300
|
Anti-D (Rh) Immunglobulin
|
CC-Pharma GmbH
|
PEI.H.11959.01.1 |
05.03.2018 |
intramuskulär, intravenös |
|
Octagam 5%
|
Normales Immunglobulin vom Menschen (IVIg)
|
Octapharma GmbH
|
PEI.H.11974.01.1 |
11.12.2018 |
intravenös |
PharmNet.Bund
|
Ig Vena 50 g/l Infusionslösung
|
Normales Immunglobulin vom Menschen (IVIg)
|
Orifarm GmbH
|
PEI.H.12001.01.1 |
19.08.2019 |
intravenös |
PharmNet.Bund
|
Octagam 5%
|
Normales Immunglobulin vom Menschen (IVIg)
|
EurimPharm Arzneimittel GmbH
|
PEI.H.12032.01.1 |
12.03.2020 |
intravenös |
|
Optiglobin 100 mg/ml
|
Normales Immunglobulin vom Menschen (IVIg)
|
Prothya Biosolutions Netherlands B.V.
|
PEI.H.12033.01.1 |
28.08.2020 |
intravenös |
PharmNet.Bund
|
Intratect
|
Immunglobulin vom Menschen (IVIg)
|
Abacus Medicine A/S
|
PEI.H.12034.01.1 |
29.04.2020 |
intravenös |
PharmNet.Bund
|
Intratect 100 g/l
|
Immunglobulin vom Menschen (IVIg)
|
Abacus Medicine A/S
|
PEI.H.12035.01.1 |
04.05.2020 |
intravenös |
PharmNet.Bund
|
Rhophylac 300
|
Anti-D (Rh) Immunglobulin
|
Abacus Medicine A/S
|
PEI.H.12036.01.1 |
29.04.2020 |
intramuskulär, intravenös |
PharmNet.Bund
|
Hepatect CP
|
Hepatitis-B-Immunglobulin vom Menschen
|
Orifarm GmbH
|
PEI.H.12039.01.1 |
29.04.2020 |
intravenös |
PharmNet.Bund
|
Octagam 5%
|
Normales Immunglobulin vom Menschen (IVIg)
|
EMRA-MED Arzneimittel GmbH
|
PEI.H.12047.01.1 |
01.10.2020 |
intravenös |
|
Rhophylac 300 Mikrogramm / 2 ml
|
Anti-D Immunglobulin aus Plasma von menschlichen Spendern
|
AxiCorp Pharma GmbH
|
PEI.H.12050.01.1 |
19.08.2020 |
intramuskulär, intravenös |
PharmNet.Bund
|
Xembify
|
Normales Immunglobulin vom Menschen (SCIg)
|
Instituto Grifols, S.A., E
|
PEI.H.12061.01.1 |
09.12.2021 |
subkutan |
PharmNet.Bund
|
Ig Vena 50 g/l Infusionslösung
|
Normales Immunglobulin vom Menschen (IVig)
|
kohlpharma GmbH
|
PEI.H.12138.01.1 |
10.01.2022 |
intravenös |
PharmNet.Bund
|
Yimmugo 100mg/ml
|
Normales Immunglobulin vom Menschen (IVIg)
|
Biotest Pharma GmbH
|
PEI.H.12143.01.1 |
11.11.2022 |
intravenös |
PharmNet.Bund
|
Hepatect CP
|
Hepatitis-B-Immunglobulin vom Menschen
|
CC-Pharma GmbH
|
PEI.H.12145.01.1 |
25.04.2022 |
intravenös |
PharmNet.Bund
|
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.