EMEA-001119-PIP03-19-M03 - paediatric investigation plan

lenvatinib

Key facts

• Invented name:
  • Kisplyx
  • Lenvima
• Active substance:
  lenvatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0528/2022
• PIP number:
  EMEA-001119-PIP03-19-M03
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thyroid cancer, follicular thyroid cancer and osteosarcoma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/12/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001119-PIP03-19-M03
• Compliance opinion date:
  13/10/2023
• Compliance outcome:
  Positive

Decision

P/0528/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (Lenvima, Kisplyx), (EMEA-001119-PIP03-19-M03)

Adopted Reference Number: EMA/929776/2022