EMA/PE/0000235505 - paediatric investigation plan

tislelizumab

Key facts

• Invented name:
  Tevimbra
• Active substance:
  tislelizumab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000235505
• PIP number:
  EMA/PE/0000235505
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/06/2025
• Compliance check done:
  No

Decision

EMA/PE/0000235505 : EMA decision of 12 June 2025 on the granting of a product specific waiver for tislelizumab (Tevimbra)

Adopted Reference Number: EMADOC-1700519818-2187650