Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Hansa Biopharma AB, P.O. Box 785, 220 07 Lund, Sweden
Idefirix 11 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). The powder is a white cake. |
Each vial contains 11 mg imlifidase produced in Escherichia coli cells by recombinant DNA technology.
After reconstitution and dilution, each mL of concentrate contains 10 mg imlifidase.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Imlifidase |
Imlifidase is a cysteine protease derived from the immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that cleaves the heavy chains of all human IgG subclasses but no other immunoglobulins. The cleavage of IgG leads to elimination of Fc-dependent effector functions, including CDC and antibody-dependent cell-mediated cytotoxicity (ADCC). By cleaving all IgG, imlifidase reduces the level of DSA, thus enabling transplantation. |
| List of Excipients |
|---|
|
Mannitol |
Idefirix is supplied in a vial (Type I glass) with a stopper (bromobutyl rubber) and flip off seal (aluminum).
Pack sizes of 1 vial or 2 × 1 vials.
Hansa Biopharma AB, P.O. Box 785, 220 07 Lund, Sweden
EU/1/20/1471/001
EU/1/20/1471/002
| Drug | Countries | |
|---|---|---|
| IDEFIRIX | Austria, Estonia, Finland, Croatia, Ireland, Israel, Italy, Lithuania, Poland, United Kingdom |
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