EMA/PE/0000182170 - paediatric investigation plan

regorafenib

Key facts

• Invented name:
  Stivarga
• Active substance:
  regorafenib
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000182170
• PIP number:
  EMA/PE/0000182170
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of all conditions contained in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/12/2024
• Compliance check done:
  Ei

Decision

EMA/PE/0000182170: EMA decision of 5 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for regorafenib (Stivarga)

Adopted Reference Number: EMADOC-1700519818-1791595