Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Atara Biotherapeutics Ireland Ltd, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
Ebvallo 2.8 × 107 – 7.3 × 107 cells/mL dispersion for injection.
| Pharmaceutical Form |
|---|
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Dispersion for injection. A translucent, colourless to slightly yellow cell dispersion. |
Ebvallo (tabelecleucel) is an allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy which targets and eliminates EBV-positive cells in a human leukocyte antigen (HLA)-restricted manner. Tabelecleucel is produced from T cells harvested from human donors. Each Ebvallo lot is tested for specificity of lysis of EBV+ targets, T-cell HLA restriction of specific lysis and verification of low alloreactivity. An Ebvallo lot is selected for each patient from the existing product inventory based on an appropriate HLA restriction.
Each vial contains 1 mL deliverable volume of Ebvallo at a concentration of 2.8 × 107 – 7.3 × 107 viable T cells/mL dispersion for injection. The quantitative information regarding actual concentration, HLA profile and patient dose calculation is provided in the Lot Information Sheet (LIS) included with the shipper used to transport the medicinal product.
The total number of vials in each carton (between 1 vial and 6 vials) corresponds to the dosing requirement for each individual patient, depending on the patient’s body weight (see sections 4.2 and 6.5).
Excipient(s) with known effect: This medicinal product contains 100 mg dimethyl sulfoxide (DMSO) per mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tabelecleucel |
Tabelecleucel is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner. Tabelecleucel has an equivalent mechanism of action to that demonstrated by endogenous circulating T cells in the donors from which the medicinal product is derived. The T-cell receptor of each clonal population within tabelecleucel recognises an EBV peptide in complex with a specific HLA molecule on the surface of target cells (the restricting HLA allele) and allows the medicinal product to exert cytotoxic activity against the EBV-infected cells. |
| List of Excipients |
|---|
|
Dimethyl sulfoxide |
Ebvallo is supplied in a cyclo-olefin copolymer 2 mL stoppered vials with a thermoplastic elastomer closure containing 1 mL deliverable volume of cell dispersion.
The carton contains a variable number of vials (between 1 vial and 6 vials) according to the patientspecific dose required.
Atara Biotherapeutics Ireland Ltd, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
EU/1/22/1700/001
| Drug | Countries | |
|---|---|---|
| EBVALLO | Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania |
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