Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Inflectra 100 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). The powder is white. |
One 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 murine hybridoma 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 (butyl) rubber stopper and an aluminium seal with a flip-off button.
Pack sizes of 1, 2, 3, 4, 5 vials.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/13/854/001
EU/1/13/854/002
EU/1/13/854/003
EU/1/13/854/004
EU/1/13/854/005
Date of first authorisation: 10 September 2013
Date of latest renewal: 21 June 2018
| Drug | Countries | |
|---|---|---|
| INFLECTRA | Albania, Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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