EMA/PE/0000302950 - paediatric investigation plan

humanised IgG4 bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor A, long form

Key facts

• Active substance:
  humanised IgG4 bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor A, long form
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000302950
• PIP number:
  EMA/PE/0000302950
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except melanoma, central 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:
  20/03/2026
• Compliance check done:
  Nein

Decision

EMA/PE/0000302950 : EMA decision of 20 March 2026 on the granting of a product specific waiver for humanised IgG4 bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor A, long form

Adopted Reference Number: EMADOC-1700519818-2919899