Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary
Regkirona 60 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to pale yellow solution with pH of 5.7– 6.3 and osmolality of 250-300 mOsmol/kg. |
Each vial contains 960 mg of regdanvimab*.
Each mL of concentrate contains 60 mg of regdanvimab.
* Regdanvimab is a recombinant human IgG1 monoclonal antibody produced through recombinant DNA technology in a mammalian cell line (Chinese Hamster Ovary).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Regdanvimab |
Regdanvimab is a recombinant human IgG1 monoclonal antibody that binds to the receptor binding domain (RBD) of the spike(s) protein of SARS-CoV-2 consequently blocking cellular entry and SARS-CoV-2 infection. |
| List of Excipients |
|---|
|
L-histidine |
Type I glass vial with a chlorobutyl rubber stopper.
Pack size of 1 vial.
Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary
EU/1/21/1597/001
| Drug | Countries | |
|---|---|---|
| REGKIRONA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania |
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