EMEA-001119-PIP02-12-M08 - paediatric investigation plan

lenvatinib

Key facts

• Invented name:
  • Lenvima
  • Kisplyx
• Active substance:
  lenvatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0280/2022
• PIP number:
  EMEA-001119-PIP02-12-M08
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Treatment of follicular thyroid cancer
  • Treatment of osteosarcoma
  • Treatment of papillary thyroid cancer
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2022
• Compliance check done:
  Jah
• Compliance procedure number:
  EMEA-C-001119-PIP02-12-M08
• Compliance opinion date:
  26/05/2023
• Compliance outcome:
  Positive

Decision

P/0280/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (Lenvima, Kisplyx), (EMEA-001119-PIP02-12-M08)

Adopted Reference Number: EMA/624967/2022