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
• Contact for public enquiries:

  Bayer AG

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2021

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)

AdoptedReference Number: EMA/627624/2021