EMA/PE/0000182333 - paediatric investigation plan

precemtabart tocentecan

Key facts

• Active substance:
  precemtabart tocentecan
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000182333
• PIP number:
  EMA/PE/0000182333
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue 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:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000182333: EMA decision of 6 December 2024 on the granting of a product specific waiver for precemtabart tocentecan

Adopted Reference Number: EMADOC-1700519818-1789267