EMA/PE/0000228283 - paediatric investigation plan

balstilimab

Key facts

• Active substance:
  balstilimab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000228283
• PIP number:
  EMA/PE/0000228283
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except melanoma, SMARCB1 (INI1) tumours, hypermutated tumours, nervous system, haematopoietic and lymphoid tissue)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/02/2025
• Compliance check done:
  Nein

Decision

EMA/PE/0000228283 : EMA decision of 28 January 2025 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for balstilimab

Adopted Reference Number: EMADOC-1700519818-1856330