EMEA-001971-PIP02-16-M04 - paediatric investigation plan

Larotrectinib

Key facts

• Invented name:
  Vitrakvi
• Active substance:
  Larotrectinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0487/2021
• PIP number:
  EMEA-001971-PIP02-16-M04
• Pharmaceutical form(s):
  • Capsule, hard
  • Oral solution
• 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:
  • Gastric use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001971-PIP02-16-M04
• Compliance opinion date:
  31/03/2023
• Compliance outcome:
  Positive

Decision

P/0487/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for larotrectinib (Vitrakvi), (EMEA-001971-PIP02-16-M04)

Adopted Reference Number: EMA/627624/2021