Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Tepkinly 4 mg/0.8 ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Colourless to slightly yellow solution, pH 5.5 and osmolality of approximately 211 mOsm/kg. |
Each 0.8 ml vial contains 4 mg of epcoritamab at a concentration of 5 mg/ml.
Each vial contains an overfill that allows withdrawal of the labelled amount.
Epcoritamab is a humanised immunoglobulin G1 (IgG1)-bispecific antibody against CD3 and CD20 antigens, produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipient with known effect: Each vial of Tepkinly contains 21.9 mg of sorbitol and 0.42 mg of polysorbate 80.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Epcoritamab |
Epcoritamab is a humanised IgG1-bispecific antibody that binds to a specific extracellular epitope of CD20 on B cells and to CD3 on T cells. The activity of epcoritamab is dependent upon simultaneous engagement of CD20-expressing cancer cells and CD3-expressing endogenous T cells by epcoritamab that induces specific T-cell activation and T-cell-mediated killing of CD20-expressing cells. |
| List of Excipients |
|---|
|
Sodium acetate trihydrate |
Type I glass vial with a bromobutyl rubber stopper coated with fluoropolymer at the contact site and aluminium seal with a plastic light blue flip off cap, containing 4 mg per 0.8 ml solution for injection.
Each carton contains one vial.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Date of first authorisation: 22 September 2023
Date of latest renewal: 17 July 2024
| Drug | Countries | |
|---|---|---|
| TEPKINLY | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom |
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