EBVALLO Resources: Support Materials & SmPC

SUMMARY OF PRODUCT CHARACTERISTICS

European Summary of Product CharacteristicsSee EU SmPC

IMPORTANT: This is an international website for EBVALLO®. The information on this website is based on the European Summary of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

SUPPORT MATERIALS

These materials are approved based on the European SmPC, please refer to the materials approved in your country.

EBVALLO Physician Guide

Couverture preparation & administration guide

EBVALLO Preparation & Administration Guide

Go Cell Therapy Onboarding

Other materials are available for you to help support your patients throughout their treatment with EBVALLO.

DO YOU HAVE A QUESTION ? CONTACT US !

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References

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

1. EBVALLO EPAR.
2. Mahadeo KM, et al. Poster 4658. Presented at ASH Annual Meeting and Exposition; Dec. 10–13, 2022; New Orleans, Louisiana, USA. New and Updated Results from a Multicenter, Open-Label, Global Phase 3 Study of Tabelecleucel (Tab-cel) for Epstein–Barr Virus-Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) Following Allogeneic Hematopoietic Cell (HCT) or Solid Organ Transplant (SOT) after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE).
3. EBVALLO Summary of Product Characteristics. December 2022.
4. Dierickx D, et al. Post-Transplantation Lymphoproliferative Disorders in Adults. N Engl J Med. 2018;378:549–562.
5. Nijland ML, et al. Epstein-Barr virus-positive posttransplant lymphoproliferative disease after solid organ transplantation: pathogenesis, clinical
manifestations, diagnosis, and management. Transplant Direct. 2016;2(1):e48.
6. Sanz J, et al. Abstract 1454. Presented at: ASH Annual Meeting and Exposition; December 11–14, 2021; Atlanta. Clinical Outcomes of Patients with Epstein–Barr Virus-Driven Post-Transplant Lymphoproliferative Disease Following Hematopoietic Stem Cell Transplantation Who Fail Rituximab:A Multinational, Retrospective Chart Review Study. Blood. 2021;138(Suppl 1):1454.
7. Dharnidharka V, et al. Abstract 2528. Presented at: ASH Annual Meeting and Exposition; December 11–14, 2021; Atlanta. Clinical Outcomes of Solid Organ Transplant Patients with Epstein-Barr Virus-Driven (EBV) Post-Transplant Lymphoproliferative Disorder (PTLD) Who Fail Rituximab Plus Chemotherapy: A Multinational, Retrospective Chart Review Study. Blood. 2021;138(Suppl 1):2528.
8. NCT03394365. Available at: https://clinicaltrials.gov/ct2/show/NCT03394365.
9. Mahadeo KM, et al. Abstract 4658. Presented at ASH Annual Meeting and Exposition; Dec. 10–13, 2022; New Orleans, Louisiana, USA. New and Updated Results from a Multicenter, Open-Label, Global Phase 3 Study of Tabelecleucel (Tab-cel) for Epstein–Barr Virus-Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) Following Allogeneic Hematopoietic Cell (HCT) or Solid Organ Transplant (SOT) after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE). Blood. 2022;140(Suppl 1):10374–10376.
10. Choquet S, et al. Abstract 258. Presented at ICML; June 18–22, 2021; Virtual Congress. Epstein-Barr virus-driven diseases: a multinational, multicohort, open-label phase 2 study to assess the efficacy and safety of tabelecleucel using an adaptive study design.

This is an international website for EBVALLO®. IMPORTANT: the information on this website is based on the European Summary of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.