Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands
Flixabi 100 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White powder. |
Each vial contains 100 mg of infliximab*. After reconstitution, each mL contains 10 mg of infliximab.
* Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Infliximab |
Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ). |
| List of Excipients |
|---|
|
Sucrose |
Type 1 glass vial with a rubber stopper and aluminium crimp protected by a plastic cap.
Flixabi is available in packs containing 1, 2, 3, 4, or 5 vial(s).
Not all pack sizes may be marketed.
Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands
EU/1/16/1106/001
EU/1/16/1106/002
EU/1/16/1106/003
EU/1/16/1106/004
EU/1/16/1106/005
Date of first authorisation: 26 May 2016
Date of latest renewal: 11 Feb 2021
| Drug | Countries | |
|---|---|---|
| FLIXABI | Austria, Cyprus, Germany, Estonia, Spain, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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