REGKIRONA Concentrate for solution for infusion Ref.[28065] Active ingredients: Regdanvimab

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

Product name and form

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.

Qualitative and quantitative composition

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
L-histidine monohydrochloride monohydrate
Polysorbate 80
L-arginine monohydrochloride
Water for injections

Pack sizes and marketing

Type I glass vial with a chlorobutyl rubber stopper.

Pack size of 1 vial.

Marketing authorization holder

Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary

Marketing authorization dates and numbers

EU/1/21/1597/001

Drugs

Drug Countries
REGKIRONA Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania

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