EMEA-003532-PIP01-23 - paediatric investigation plan

budigalimab

Key facts

• Active substance:
  budigalimab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMEA-003532-PIP01-23
• PIP number:
  EMEA-003532-PIP01-23
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms except melanoma, central nervous neoplasms, haematopoietic and lymphoid tissues neoplasms
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/01/2025
• Compliance check done:
  No

Decision

EMEA-003532-PIP01-23 : EMA decision of 28 January 2025 on the granting of a product specific waiver for budigalimab

Adopted Reference Number: EMADOC-1700519818-1859887