Coagulation Factors
Coagulation factors are protein components of the blood which serve blood coagulation.
Name
|
Marketing Authorisation Holder
|
License Number
|
License Date
|
Further Information
|
Faktor VIII SDH INTERSERO 250
|
Intersero GmbH
|
16844.00.00 |
06.11.1991 |
PharmNet.Bund
|
Faktor VIII SDH INTERSERO 500
|
Intersero GmbH
|
16844.01.00 |
06.11.1991 |
PharmNet.Bund
|
Faktor VIII SDH INTERSERO 1000
|
Intersero GmbH
|
16844.02.00 |
06.11.1991 |
PharmNet.Bund
|
Recombinate Antihaemophilie Faktor (rekombinant) 1000
|
Takeda GmbH
|
28530.02.00 |
30.07.1993 |
PharmNet.Bund
|
ADVATE
|
Takeda Manufacturing Austria AG
|
EU/1/03/271 |
02.03.2004 |
EPAR ADVATE
|
NovoThirteen
|
Novo Nordisk A/S, Denmark
|
EU/1/12/775 |
03.09.2012 |
EPAR: NovoThirteen
|
Voncento
|
CSL Behring GmbH
|
EU/1/13/857 |
12.08.2013 |
EPAR: Voncento
|
NovoEight
|
Novo Nordisk A/S, Denmark
|
EU/1/13/888 |
13.11.2013 |
EPAR: NovoEight
|
Nuwiq
|
Octapharma AB, Stockholm
|
EU/1/14/936 |
22.07.2014 |
|
Rixubis
|
Baxter Innovations GmbH
|
EU/1/14/970 |
19.12.2014 |
EPAR: Rixubis
|
Obizur
|
Baxalta Innovations GmbH, A
|
EU/1/15/1035 |
11.11.2015 |
EPAR: Obizur
|
Elocta
|
Swedish Orphan Biovitrum AB (publ)
|
EU/1/15/1046 |
19.11.2015 |
EPAR: Elocta
|
Kovaltry
|
Bayer AG
|
EU/1/15/1076 |
18.02.2016 |
EPAR Kovaltry
|
Coagadex
|
Bio Products Laboratory Ltd., UK-Hertfordshire
|
EU/1/16/1087 |
16.03.2016 |
EPAR: Coagadex
|
Idelvion
|
CSL Behring GmbH
|
EU/1/16/1095 |
11.05.2016 |
EPAR: Idelvion
|
Alprolix
|
Swedish Orphan Biovitrum AB (publ)
|
EU/1/16/1098 |
12.05.2016 |
EPAR: Alprolix
|
Afstyla
|
CSL Behring GmbH
|
EU/1/16/1158 |
04.01.2017 |
EPAR: Afstyla
|
Vihuma
|
Octapharma AB, Stockholm
|
EU/1/16/1168 |
13.02.2017 |
EPAR: Vihuma
|
Refixia
|
Novo Nordisk A/S, Denmark
|
EU/1/17/1193 |
02.06.2017 |
EPAR: Refixia
|
Adynovi
|
Baxalta Innovations GmbH, A
|
EU/1/17/1247 |
08.01.2018 |
EPAR: Adynovi
|
Veyvondi
|
Baxalta Innovations GmbH
|
EU/1/18/1298 |
31.08.2018 |
EPAR: Veyvondi
|
Jivi
|
Bayer AG
|
EU/1/18/1324 |
22.11.2018 |
EPAR: Jivi
|
Esperoct
|
Novo Nordisk A/S, Dänemark
|
EU/1/19/1374 |
20.06.2019 |
EPAR: Esperoct
|
Cevenfacta
|
Laboratoire francais du Fractionement et des Biotechnologies, Frankreich
|
EU/1/22/1664 |
15.07.2022 |
EPAR: Cevenfacta
|
Altuvoct
|
Swedish Orphan Biovitrum AB, Schweden
|
EU/1/24/1824 |
17.06.2024 |
EPAR: Altuvoct
|
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. 529 in BAnz AT 30.05.2025 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.