EMA grants Tevimbra paediatric waiver across all age groups

The European Medicines Agency granted Tevimbra, or tislelizumab, a product-specific paediatric waiver covering all age groups in a June 12, 2025 decision first published on Oct. 14, 2026.

Evidence grade: Claim (no study cited). The EMA source is a regulatory record, not a clinical study, and it exempts 1 medicine from a Paediatric Investigation Plan requirement rather than reporting patient outcomes.

A Paediatric Investigation Plan, or PIP, sets out how a medicine developer studies a product in children when paediatric data are required. A waiver means the agency has decided those paediatric studies are not required for the covered scope.

The EMA record lists the decision type as a waiver in all age groups for all conditions or indications. The decision and PIP number is EMA/PE/0000235505.

The product is listed as Tevimbra, with tislelizumab as the active substance. The pharmaceutical form is a solution for injection, the route is subcutaneous use, and the therapeutic area is neoplasms, including benign, malignant and unspecified neoplasms.

The condition entry specifies treatment of all conditions in malignant neoplasms, excluding central nervous system, haematopoietic and lymphoid tissue. The EMA page lists Beone Medicines Ireland Limited as the contact for public enquiries.

The record does not provide efficacy data, safety data, commercial details or a reason for the waiver. It also says no compliance check has been done.

Source: European Medicines Agency regulatory record, published Oct. 14, 2026.

Atlas360 reports health research and does not provide medical advice.