Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
TALVEY 2 mg/mL solution for injection.
TALVEY 40 mg/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is colourless to light yellow, with pH of 5.2 and osmolality of 287-290 mOsm/kg. |
TALVEY 2 mg/mL solution for injection: One 1.5 mL vial contains 3 mg of talquetamab (2 mg/mL).
TALVEY 40 mg/mL solution for injection: One 1 mL vial contains 40 mg of talquetamab (40 mg/mL).
Talquetamab is a humanised immunoglobulin g4-proline, alanine, alanine (IgG4-PAA) bispecific antibody directed against G protein-coupled receptor family C group 5 member D (GPRC5D) and the CD3 receptors, produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Talquetamab |
Talquetamab is a immunoglobulin G4 proline, alanine, alanine (IgG4 PAA) bispecific antibody directed against GPRC5D and the CD3 receptor on T Cells. Talquetamab promotes enhanced T cell-mediated cytotoxicity through recruitment of CD3-expressing T cells to GPRC5D-expressing cells. Based on the expression of GPRC5D on plasma cells with minimal to no expression detected on B cells and B cell precursors, talquetamab targets multiple myeloma cells particularly. |
| List of Excipients |
|---|
|
EDTA disodium salt dihydrate |
TALVEY 2 mg/mL solution for injection: 1.5 mL solution for injection in a Type 1 glass vial with an elastomeric stopper and an aluminium seal with a light green flip-off cap containing 3 mg of talquetamab.
Pack size of 1 vial.
TALVEY 40 mg/mL solution for injection: 1 mL solution for injection in a Type 1 glass vial with an elastomeric stopper and an aluminium seal with a violet flip-off cap containing 40 mg of talquetamab.
Pack size of 1 vial.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/23/1748/001 (2 mg/ml)
EU/1/23/1748/002 (40 mg/ml)
| Drug | Countries | |
|---|---|---|
| TALVEY | Austria, Cyprus, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom, United States |
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